Health & Beauty

It may take decades for a large scientific installation to achieve its ultimate goal. However, in the process of its completion and research, it was able to "lay eggs along the way" and "incubate" more devices and facilities.

On the circular synchrotron "runway" with a diameter of more than 7 meters, the proton beam is accelerating and "running" in circles. When they turn millions of times and speed up to about two-thirds of the speed of light, they will be introduced into the treatment room along the high-energy transport line, and will be precisely irradiated to the patient's tumor site "directed blasting", with less radiation to surrounding normal tissues ...

Recently, the author came to the Tumor Proton Center of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine in Jiading New City, Shanghai, to visit the first domestically produced proton therapy demonstration device co-operated by the Chinese Academy of Sciences, the Ministry of Science and Technology, the National Health Commission and Shanghai. Despite the impact of this round of epidemic in Shanghai, the project team worked hard to overcome difficulties and carried out clinical trials as scheduled. On June 3, as the last patient walked out of the 180-degree rotating beam treatment room, the treatment of the clinical trial subjects in the two treatment rooms of the first registration unit ended successfully.

"We hope that the localization of proton devices is not only the success of a device, but also the success of productization and the success of the treatment model. Through this program, domestic tumor treatment will enter a new stage, and tumors will no longer be scary." China Ning Guang, academician of the Academy of Engineering and president of Ruijin Hospital, said.

The epidemic has not slowed the speed of clinical trials

During the epidemic, patients in the Tumor Proton Center of Ruijin Hospital were admitted to the 180-degree rotating beam treatment room for treatment as scheduled. This is the second treatment room in which a domestic proton therapy device has been put into clinical trials after the fixed beam treatment room. Degree Rotating Beam Therapy Room.

"This system can accurately irradiate the tumor site from multiple angles and reduce radiation damage to normal tissues," said Chen Haitao, vice president of Ruijin Hospital. "Completing the world's most advanced 360-degree rotating stent clinical trial is our next work goal. "

It is reported that the first registration unit of the domestic proton therapy device includes two clinical trials of fixed beam and 180-degree rotating beam. After strict screening according to the inclusion criteria of the clinical trial protocol and the indications of proton therapy, a total of 47 subjects with solid tumors in different parts of the body such as head and neck, chest, abdomen, pelvis and spine were treated. their common characteristics.

Chen Jiayi, director of the Radiotherapy Department of Ruijin Hospital, said that the unique and superior physical properties of proton beams can greatly reduce the irradiation volume of normal tissues, thereby effectively reducing the side effects of radiotherapy, and will partially reduce the radiation tolerance of important normal tissues under photon therapy technology. Limited and incurable tumors provide curable opportunities, and have irreplaceable advantages in the treatment of head and neck tumors, deep pelvic tumors, eye tumors, and children's tumors, especially helping to preserve the quality of life of patients. Taking a 32-year-old young patient as an example, she said: "The patient is almost blind due to chordoma at the base of the skull, and the lesions are extensive and adjacent to important tissue structures. While eliminating the tumor, proton therapy maximizes protection of important tissues. The patient has seen significant improvement in vision and visual field in only about 10 treatments."

The interview learned that some clinical trials have gone through the most severe period of this round of epidemic in Shanghai. In order to ensure the reception of the treatment system and clinical trials, the team closed the loop in the Tumor Proton Center of Ruijin Hospital for more than 80 days, overcame various difficulties and influences, and ensured that all subjects successfully completed the expected treatment.

Next, the team will continue to pay close attention to the follow-up of the subjects. It is expected to complete the 3-month follow-up of the subjects' efficacy and acute toxicity in September 2022 to form a clinical trial summary report and submit the product registration application, which is expected to be completed in January 2023. Quarterly open to social patients, officially put into clinical use.

In addition, the commissioning and third-party testing of the 360-degree rotating beam and the eye treatment room will be fully carried out after the epidemic, and strive to complete the registration test by the end of the year and prepare for the clinical trial of the two treatment rooms of the second registration unit.

Independent innovation to break through "stuck neck"

The main methods of modern anti-tumor treatment include surgery, drugs and radiation therapy. Among them, proton therapy represents the commanding heights of radiotherapy technology. It was proposed by American scientists in the 1940s and developed rapidly in the early 21st century.

It is worth noting that there are more than 100 proton therapy centers in the world, but most of them are located in developed countries such as Europe, America and Japan. my country's proton therapy devices rely on imports, and the construction cost and operation and maintenance costs are high, which not only causes the scarcity of treatment resources, but also leads to high treatment costs. The localization of proton devices is expected to greatly reduce equipment costs and medical costs, and provide more accessible advanced treatment technologies and equipment for many patients with malignant tumors.

The proton device is the crystallization of another major scientific device in Shanghai, Shanghai Light Source "laying eggs along the way". Ruijin medical staff, scientists, and operation and maintenance teams have united and worked together to tackle key problems, so that this new cancer treatment technology can also "fly" into the area. Common patient's home.

Chen Zhiling, a researcher at the Shanghai Institutes for Advanced Study of the Chinese Academy of Sciences and deputy director of the Particle Beam Application Technology Department of the Shanghai Light Source, said that the synchrotron ranks first in the core technology of proton therapy devices, and its domestic breakthrough benefits from the Shanghai Light Source, which is a high-performance first Three generations of synchrotron radiation light sources, the light source energy ranks fourth in the world.

The domestic proton therapy device is a "miniature version" of Shanghai Light Source, and even an "upgraded version". "The energy generated by our device can meet the needs of clinical treatment. The principle is a synchrotron, about one-twentieth the size of the Shanghai Light Source. The difference is that one uses protons and the other uses electrons." Chen Zhiling said.

As a medical product serving the common people, the device also integrates many medically necessary treatment systems, which Shanghai Light Source does not have. For example, pencil beam spot scanning technology precisely hits the proton beam at the edge and interior of irregular lesions, image guidance and respiratory motion management can avoid errors caused by tumor movement with breathing, and so on.

The localization of proton devices has undergone long-term exploration. According to Zhao Zhentang, academician of the Chinese Academy of Engineering, researcher of the Shanghai Institutes for Advanced Study of the Chinese Academy of Sciences, and director of the Shanghai Light Source Science Center, the first domestic proton therapy device was established in 2012. Under the support of the key research and development projects of the Ministry of Science and Technology, the Shanghai Institute of Applied Physics, Chinese Academy of Sciences, Shanghai Light Source Science Center, Shanghai Advanced Research Institute, Chinese Academy of Sciences, Shanghai Aipuqiang Particle Equipment Co., Ltd., Ruijin Hospital and related manufacturers cooperate in research and development to jointly promote production, learning, research, Medical collaboration and integrated development.

More than a "0 to 1" breakthrough

Not only the breakthrough of "0 to 1" equipment, but also the industrialization process of "1 to 100".

It is understood that cost and treatment efficiency determine the possibility of marketization of proton therapy devices. The unit plans to reduce construction costs to 80% of imported units, and operation and maintenance costs to 60%. In addition, a proton therapy device usually reaches its most efficient state of use after three years from the time it is put into clinical use.

"There are many cancer patients who need radiation therapy, but the services that proton therapy can provide are very limited at this stage, and we must select the patients who can benefit most from proton therapy. The existing photon therapy devices can already We will not give priority to recommending proton therapy if we get very satisfactory curative effect and low side effects." Chen Jiayi said.

On June 3, Shanghai United Investment Co., Ltd., Ruijin Hospital and Shanghai Aipuqiang Particle Equipment Co., Ltd. jointly signed a cooperation agreement on the promotion and application of the Ruijin program of the proton therapy project on the basis of the original "Cooperation Agreement on Promoting the Industrialization of Domestic Proton Therapy Devices". , The “Ruijin Plan” for the integrated construction of a replicable and scalable tumor proton center is taking shape.

Chen Haitao explained that the "Ruijin Plan" of the Tumor Proton Center is the development of the first domestic proton therapy demonstration device and the condensed wisdom and experience in the construction of the Tumor Proton Center of Ruijin Hospital. Including the development of proton devices, product upgrades, treatment guidelines, operation management, business benefits, and preparation of proton centers, etc., from multiple dimensions such as clinical needs, application, verification, promotion, etc., to form a systematic, standardized and standardized approach to tumor treatment. promotion plan.

"We are not only going to make a device, but the future goal is to promote the replicable solution of proton therapy, realize the miniaturization of proton therapy device in terms of core technology, and form a series of supporting standards and specifications in diagnostic technology." Ning Guang said, "The incidence of tumors remains high, and it is a heavy burden for patients to travel thousands of miles to Shanghai. In the future, we hope to promote the establishment of small tumor centers in some prefecture-level cities to further reduce treatment costs."