Phase II Trial: Carbon Ion + Gemcitabine for Locally Advanced Pancreatic Cancer – Recruitment

Phase II Trial: Carbon Ion + Gemcitabine for Locally Advanced Pancreatic Cancer – Recruitment Announcement

I. Research Background

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 advance the high-quality development of heavy-ion medicine in China, leverage our extensive clinical experience, deepen clinical translational research, and support iterative upgrades of heavy-ion therapy technology, Gansu Wuwei Cancer Hospital Lanzhou Campus is now officially launching a Phase II clinical study titled "Carbon Ion Radiotherapy Combined with Concurrent Gemcitabine Chemotherapy for Locally Advanced Pancreatic Cancer." This study aims to improve the local control rate of locally advanced pancreatic cancer and enhance long-term patient survival outcomes. The project has passed scientific review and ethics committee approval, and we are now publicly recruiting participants.

II. Research Objectives

The Lanzhou Campus of Gansu Wuwei Cancer Hospital will initiate this clinical trial in May 2026. The Lanzhou Campus of Gansu Wuwei Cancer Hospital is conducting a Phase II clinical study titled "Heavy Ion Radiotherapy Combined with Concurrent Gemcitabine Chemotherapy for Locally Advanced Pancreatic Cancer." This study aims to improve the local control rate and long-term survival of locally advanced pancreatic cancer. The project has passed scientific review for clinical research and has been approved by the Medical Ethics Committee. Recruitment of participants is now open to the public.

III. Inclusion Criteria

1. Aged between 18 and 70 years;

2. Pathologically diagnosed with pancreatic cancer;

3. Meet the criteria for locally advanced pancreatic cancer, with no distant metastasis, and maximum tumor diameter ≤ 6 cm;

4. No prior local treatments such as surgery or seed implantation;

5. Generally good performance status, with no organ dysfunction, and able to tolerate the proposed treatment;

6. Willing to voluntarily participate in the study and able to comply with the treatment and follow-up schedule.

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

IV. Exclusion Criteria

1. Pancreatic cancer not confirmed by pathology;

2. Presence of distant metastasis;

3. Prior treatment for pancreatic cancer or prior upper abdominal radiotherapy, and/or active inflammatory bowel disease, active gastric/duodenal ulcer;

4. Presence of iatrogenic implants that conflict with radiotherapy at this center;

5. Pregnant or lactating women;

6. Patients with active HIV or syphilis infection;

7. Patients with severe comorbidities or poor compliance who cannot accept or complete follow-up;

8. Currently participating in another clinical study or not yet past the washout period for another clinical trial;

9. Persons without civil capacity or with limited civil capacity;

10. Unwilling or unable to sign informed consent.

V. Patient Rights

1. Supported by dedicated research funding, receive carbon ion therapy free of charge;

2. Benefit from a pancreatic cancer multidisciplinary team (MDT) composed of renowned experts from Peking University Third Hospital and other top institutions, with a personalized treatment plan tailored for you;

3. Receive regular close follow-up by a specialized team after treatment, along with guidance on subsequent diagnosis and care.

If you are interested in participating in this study or would like more detailed information, you may visit the Lanzhou Campus of Gansu Wuwei Tumor Hospital for consultation.

VI. Contact Information

Clinic Address: Lanzhou Campus of Gansu Wuwei Cancer Hospital (No. 100 Yanbei Road, Chengguan District, Lanzhou City)

Consultation Hotline: Director Qiao Hongmei – +86 133 7938 9622

Evaluation Process: Submit documents → MDT assessment → Screening and enrollment → Simulation and treatment → Regular follow-up

Lanzhou Campus, Gansu Wuwei Cancer Hospital

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.