The first in China to implement proton and photon space division radiotherapy si

Recently, the first patient in Anhui Province to undergo proton spatial fractionation radiotherapy was discharged smoothly. Reporters learned from the Ion Medical Center of the First Affiliated Hospital of University of Science and Technology of China (hereinafter referred to as "Hefei Ion Medical Center") that the hospital is the first medical center in China to implement proton and photon spatial fractionation radiotherapy technology simultaneously, which also fills the gap in spatial fractionation radiotherapy in Anhui Province.

As the first radiotherapy center in China to introduce the Varian proton therapy system, in April of this year, the Hefei Ion Medical Center officially opened, introducing proton radiotherapy technology to Hefei, Anhui. In July of this year, the Hefei Ion Medical Center innovated on the basis of proton radiotherapy and carried out the first photon and proton spatial fractionation radiotherapy in the province, which is also the first time a domestic team has applied spatial fractionation radiotherapy technology to photon and proton radiotherapy.

It is worth looking forward to that the second phase of the Hefei Ion Medical Center is currently independently developing a domestically produced proton therapy system, creating an innovative model that combines "proton medical treatment + research and development manufacturing". After the domestic equipment in the second phase is verified, the center will become the second unit in the world to have two treatment devices at the same location, following the Massachusetts General Hospital (Massachusetts General Hospital affiliated with Harvard Medical School).

01

The first application by the domestic team

Compared with single proton radiotherapy, the addition of spatial fractionation radiotherapy technology can be described as a "strong alliance", which can further increase the tumor irradiation dose and reduce the irradiation dose of normal tissues, achieving the purpose of improving local control rate and survival rate, and reducing toxic and side effects to protect important organs. It is reported that many top international medical centers are gradually carrying out spatial fractionation radiotherapy. At present, more than 10 patients in the Hefei Ion Medical Center have accepted this treatment technology.Stereotactic body radiation therapy (SBRT), also known as spatially fractionated radiotherapy, has a history spanning over a century. Its principle differs from that of standard radiotherapy because it treats the entire tumor with an inhomogeneous dose distribution, effectively targeting the tumor while keeping the surrounding normal tissue within a tolerable range. With the background of new computer technology applications and the support of advanced instrumentation, clinically, the dose intensity distribution is adjusted so that the tumor receives the maximum radiation dose while the normal tissue receives the minimum, effectively protecting the normal tissue and improving the therapeutic gain ratio. The medical advantages of SBRT lie in increasing firepower (high biological effective dose, BED), enhancing precision, and reducing toxicity.

Several top medical centers around the world are gradually adopting SBRT. The following is an experience with SBRT from the Mayo Clinic in the United States.

The Hefei Ion Medical Center has conducted spatially fractionated radiotherapy for two patients using photons and protons. One case involved metastatic retroperitoneal lymph nodes from hepatocellular carcinoma, and the other was for the treatment of primary liver cancer within the liver, both with relatively large local tumor volumes (>50cc). Below is a schematic diagram of the patient's plan.

President Yuan Shuanghu and Director Zhou Tao led the team in conducting a detailed analysis and explanation of the cases, including details such as target delineation, treatment prescription, and precautions during treatment. They also introduced the development history and current status of spatially fractionated therapy.

Particle therapy, including proton therapy, is expected to improve the dose distribution of SBRT and reduce exposure to surrounding normal tissues. Moreover, due to the limited range of proton beams (which can be controlled based on the selected energy) and the sharp dose fall-off at the end of the Bragg peak, there is essentially no exit dose to the tissues beyond the tumor volume. The center applies proton pencil beam scanning (PBS) irradiation systems, using proton spots and optimizing the position, weight, and energy of the spots to deliver the dose to the target area. Proton therapy, especially in the form of PBS, is expected to further improve the dose distribution of SBRT.

Overall, the advantages of spatially fractionated radiotherapy include:

▶ Increasing the tumor radiation dose to achieve the goal of improving local control rates and survival rates;

▶ Reducing the radiation dose to normal tissues, which can decrease side effects and protect important organs;▶ The application of new technologies has changed the pattern of fractionated irradiation for certain tumors;

▶ The increase in treatment methods means that some tumors that cannot be treated with conventional radiation in clinical settings can be completed through SFRT (Stereotactic Fractionated Radiation Therapy).

02

The first domestically produced superconducting proton radiotherapy system

is about to enter clinical use.

On the morning of April 3, 2024, the Ion Medical Center of the First Affiliated Hospital of University of Science and Technology of China (Hefei Ion Medical Center) officially commenced operations, marking it as the first comprehensive proton therapy center fully operational in Anhui Province.

The first phase of the proton therapy project covers an area of approximately 70 acres with a construction area of about 34,000 square meters, including outpatient, medical technology, inpatient, and auxiliary service facilities, with a total of 44 beds. It is equipped with the internationally advanced and mature Varian ProBeam "3+1+1" (three rotating beam treatment rooms, one fixed beam treatment room, and one research room) proton therapy system, and features a radiotherapy talent training center and an international academic exchange center, serving as a comparative verification device for independently developed proton equipment.The much-anticipated Phase II first domestic proton therapy system medical verification base project covers an area of about 24 acres, with a construction area of approximately 14,000 square meters, equipped with domestic superconducting cyclotron proton therapy systems and auxiliary service facilities. It features the domestically developed Capro-X1 proton therapy system by Hefei CAS Ion Medical Equipment Co., Ltd. (one rotating beam treatment room and one fixed beam treatment room), serving as a "showcase" for the future marketization of domestic proton equipment.

It is reported that the proton therapy equipment utilizes a superconducting cyclotron accelerator with a radius of 1.5 meters, weighing 70 tons, and an energy level of 240MeV, capable of producing continuous waves. It is characterized by high beam current and good stability (supporting the novel proton Flash therapy and pencil beam scanning), and is considered the "heart" of the Hefei domestic superconducting proton radiotherapy system.

The treatment system also includes a 360° rotatable gantry, in conjunction with a robotic arm, allowing for "irradiation" from various angles to meet the treatment needs of tumors in multiple locations. The treatment system integrates internationally advanced treatment planning systems, radiotherapy information management systems, 3D image guidance systems, respiratory gating systems, the latest pencil beam scanning technology, and a six-dimensional robotic patient positioning system, achieving integrated proton radiotherapy from hardware to software.

In June of this year, the Beijing Medical Device Testing Institute (hereinafter referred to as "the Institute") dispatched a team of electrical safety engineers to Hefei, Anhui, to conduct on-site inspections of the "CAS Ion domestic superconducting proton radiotherapy system."

Completing the system inspection will secure valuable time for subsequent clinical trials and registration reviews, benefiting patients more quickly and effectively. Previously, a reporter learned from the Hefei Ion Medical Center that, with the approval of the medical service price authority, the current charging standard for the imported proton therapy system configured in the first phase of the center is a maximum of 240,000 yuan per course for the same indication. The first radiotherapy session for the same indication is priced at 60,000 yuan per session, and subsequent sessions are 15,000 yuan per session.

In the future, once the Phase II of the Hefei Ion Medical Center achieves equipment domestication, the cost of proton therapy is expected to become more affordable.Domestic Equipment Achieves Zero Breakthroughs Successively

Proton therapy can be considered one of the most advanced radiotherapy methods for treating tumors currently available, hailed as the "tumor targeted demolition device" and the "pearl of the crown in tumor radiotherapy." In recent years, significant technological progress has been made in domestically produced proton and heavy ion therapy equipment.

In March 2020, after eight years of construction, China's first domestically produced heavy ion tumor treatment system—the Wuwei Heavy Ion Center—officially began clinical application. The domestic heavy ion accelerator, developed by the Institute of Modern Physics of the Chinese Academy of Sciences, has made China the fourth country in the world with this independent intellectual property right, following Japan, Germany, and the United States.

After successfully signing the contract for the first heavy ion accelerator, Lanzhou Kejin Taiji New Technology Co., Ltd. (hereinafter referred to as "Lanzhou Taiji") has successively signed contracts for medical heavy ion accelerator projects in Lanzhou, Putian, Wuhan, Hangzhou, Nanjing, Changchun, Jinan, and other regions, undertaking the construction tasks related to carbon ion therapy systems. It is understood that as of May this year, Lanzhou Taiji has undertaken the construction of 8 medical heavy ion accelerator devices in China, with 3 completed and 5 under construction.

On April 11, 2024, the carbon ion therapy system produced by Lanzhou Taiji for Zhejiang Cancer Hospital obtained tuning permission from the National Environmental Protection Department, and on April 13, the accelerator tuning was completed. The terminal particle count of 400 MeV/u carbon ions reached 1.5E9ppp, setting a new historical high for beam intensity, achieved in just about 30 hours, demonstrating the excellent performance and extremely high stability and reliability of the domestic carbon ion therapy system.

The first domestic proton therapy system (SAPT-PS-01) was developed by the Shanghai Institute of Applied Physics of the Chinese Academy of Sciences, and the industrialization was undertaken by Shanghai Ai Pu Qiang Company. It began trial operation at the Ruijin Hospital Tumor Proton Center on July 19, 2023, and officially started operation on November 24, 2023, after the charging standard was approved, and was put into clinical application at Ruijin Hospital in Shanghai. In March of this year, the number of clinical treatment patients for the first domestic proton therapy system has exceeded 100 cases.

It is understood that the 360-degree rotating treatment system currently being debugged at Ruijin Hospital in Shanghai is more compact than the 180-degree system already in use. The new generation system has a broader range of rotation, more precise adaptive systems, and is more conducive to improving treatment flexibility and efficiency. According to the current plan, the system is expected to be debugged and completed in October this year.

In August 2024, the national first electronic Flash radiotherapy equipment—e-Flash, developed by Zhongjiu Flash, a subsidiary of Changhong Holding Group, is about to complete all type inspections and enter the clinical trial phase.According to reports, based on the current state of research, the laboratory has conducted hundreds of experiments on the abdomen, chest, and skin of experimental animals, and has found that FLASH radiotherapy has shown significant effects. It not only treats tumors but also causes less radiation damage to normal tissues, which can significantly reduce side effects.

At present, the first batch of FLASH radiotherapy equipment in the country has entered the Central Hospital of Mianyang and is about to enter the clinical trial phase. In the future, cancer treatment will be more efficient.

In the global proton therapy market, Varian from the United States and IBA from Belgium share the market equally and hold a dominant position; Hitachi from Japan, Mitsubishi, Mevion, Optivus, and others also have a share in the proton therapy market. There are less than ten proton therapy equipment suppliers in the world, and the top three manufacturers have occupied nearly 80% of the global market share.

On February 8, 2024, the National Health Commission issued the "Notice on Adjusting the 'Fourteenth Five-Year Plan' for the Configuration of Large Medical Equipment", clarifying that in order to meet the diverse diagnostic and treatment service needs of the people and support the healthy and orderly development of social medical institutions, it was decided to adjust the "Fourteenth Five-Year Plan" for the configuration of large medical equipment. During the "Fourteenth Five-Year Plan" period, the national heavy ion proton radiotherapy system configuration plan will add 8 (sets), which will be used exclusively for social medical institutions, implemented annually, and the access standards remain unchanged.

The announcement from the National Health Commission shows that during the "Fourteenth Five-Year Plan" period, 21 hospitals have been approved for the configuration permit of heavy ion proton radiotherapy systems, among which 10 hospitals have obtained the configuration permit for multi-room proton radiotherapy systems, 4 hospitals have obtained the configuration permit for single-room proton radiotherapy systems, and 7 hospitals have obtained the configuration permit for heavy ion systems.

With the breakthrough of domestic proton and heavy ion treatment equipment, the popularization of proton therapy will inevitably be further advanced. In the future, the home of medical equipment will also pay close attention to the latest developments in the field of proton therapy in China.