Full Initiation of Clinical Study on Zero Out-of-Pocket Heavy Ion Therapy for Breast Cancer

Announcement: Full Initiation of Clinical Study on Zero Out-of-Pocket Heavy Ion Therapy for Breast Cancer

The Lanzhou Campus of Gansu Wuwei Cancer Hospital is the second heavy-ion clinical center in China operating with domestically developed proprietary intellectual property rights, managed by Gansu Wuwei Cancer Hospital. Together with the first Chinese heavy-ion treatment system, the second Chinese heavy-ion tumor treatment system commenced clinical operation at the Lanzhou Campus of Gansu Wuwei Cancer Hospital on November 15, 2024. To date, our hospital has completed heavy-ion and photon therapy for over 530 patients, covering diseases such as lung cancer, pancreatic cancer, liver cancer, and glioblastoma.

To further support the high-quality development of China's heavy-ion technology, build upon previous work, deepen clinical application research, and vigorously promote iterative upgrades of heavy-ion therapy technology, we are now launching the "Clinical Study of Curative Carbon Ion Radiotherapy for Breast Cancer." This study aims to align with international standards, establish a clinical treatment standard for Chinese heavy-ion systems in breast cancer therapy, and pursue better patient outcomes.

Clinical Study on Radical Carbon Ion Radiotherapy for Breast Cancer

Research Purpose

This study is a single-center, single-arm, prospective Phase II clinical trial, enrolling a total of 42 patients. Patients with cT1-3N0-2aM0 breast cancer will be selected to receive curative carbon ion radiotherapy for breast cancer using a carbon ion accelerator, with the aim of avoiding surgery and preserving the breast. The study will observe the efficacy and safety of carbon ion radiotherapy for breast cancer.

Selection Criteria

(1) 18 years ≤ age ≤ 65 years; pathologically confirmed primary breast cancer; clinical stage cT1-3N0-2aM0 (UICC 8th edition);

(2) No prior initial treatment such as endocrine therapy, targeted therapy, or chemotherapy;

(3) Not participating in other similar studies;

(4) Willing to voluntarily sign the informed consent form and commit to complying with follow-up.

The above criteria are the main eligibility requirements. Final enrollment eligibility will be determined by the investigator in accordance with the study protocol.

Participation Content

(1) Screening: After signing the informed consent form, physical examination, imaging (CT/MRI/PET-CT), and laboratory tests will be performed.

(2) Treatment: Carbon ion radiotherapy: 48 Gy (RBE) to the whole breast and lymphatic drainage area, with a boost to the primary tumor up to 72–80 Gy (RBE). Concurrent individualized comprehensive treatment will be administered according to the latest NCCN treatment guidelines.

(3) Follow-up: Regular follow-up visits will be conducted at 1, 3, 6, and 12 months after treatment, then once every six months thereafter, for a total duration of 10 years.

Patient Rights

(1) The hospital will provide research funding to the expert team to cover the patients' heavy ion therapy costs.

(2) A breast cancer multidisciplinary team (MDT) will develop a personalized treatment plan for you.

(3) After treatment, we will conduct close follow-up with you and provide guidance on subsequent treatment options

Contact Information

Contact Person:

Lanzhou Campus of Gansu Wuwei Cancer Hospital

Zhao Fengju +86 13919219021

Lanzhou Campus of Gansu Wuwei Cancer Hospital

Li Xiaojun +86 13150160200

Gansu Wuwei Cancer Hospital, Lanzhou Campus

The Lanzhou Campus of Gansu Wuwei Cancer Hospital is the second heavy-ion clinical center in China operating with domestically developed proprietary intellectual property rights, managed by Gansu Wuwei Cancer Hospital. Together with the first Chinese heavy-ion treatment system, the second Chinese heavy-ion tumor treatment system commenced clinical operation at the Lanzhou Campus of Gansu Wuwei Cancer Hospital on November 15, 2024. To date, our hospital has completed heavy-ion and photon therapy for over 530 patients, covering diseases such as lung cancer, pancreatic cancer, liver cancer, and glioblastoma.

Our hospital has established an outstanding talent system, bringing together an expert workstation led by 50 top-tier authorities, including Professor Shen Wenjiang, Emeritus Professor of the Department of Radiation Oncology at Peking University Health Science Center, and Professor Xu Bo, Standing Committee Member of the Chinese Society of Radiation Oncology. Professor Wang Junjie, Chairman of the Chinese Society of Radiation Oncology, serves as the hospital director, providing strong technical support for heavy-ion therapy.

In addition, our hospital is equipped with a series of cutting-edge radiotherapy devices, including the Varian VitalBeam medical linear accelerator, the Elekta Infinity four-dimensional image-guided radiotherapy linear accelerator, a 3.0T simulation and positioning MRI, a GE 256-slice high-end CT, and a Varian Iridium-192 imported afterloader. These hardware facilities lay a solid foundation for heavy-ion therapy, ensuring high efficiency and precision throughout the treatment process.

With the goal of building a comprehensive, full-life-cycle tumor treatment system, our hospital has established departments including the Department of Radiation Oncology, Department of Medical Oncology/Hematology, Department of Surgical Oncology, Department of Integrated Traditional Chinese and Western Medicine for Cancer Rehabilitation, Minimally Invasive Interventional Center, Department of Critical Care Medicine, and Digestive Endoscopy Center. We provide heavy-ion radiotherapy, photon radiotherapy, chemotherapy, minimally invasive interventional therapy, and comprehensive medical and surgical treatments for cancer.

Our hospital is equipped with advanced diagnostic technologies and facilities. We have medical technology departments such as the Department of Medical Imaging, Department of Laboratory Medicine, Department of Ultrasound Medicine, Blood Bank, and Hematology Center Laboratory, offering CT/MRI diagnostic imaging, medical laboratory testing, ultrasound diagnosis and interventional procedures, and bone marrow morphology examinations to meet patients' diagnostic needs.

The Minimally Invasive Interventional Center is equipped with an Iodine-125 brachytherapy system for tumors, a body implant navigation and positioning system, a GE digital subtraction angiography (DSA) unit, a microwave thermocoagulation therapy device, and an argon-helium cryoablation system. These enable precise treatment for cancer patients through embolization, ablation, and brachytherapy.