Status:
RECRUITING
SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive s...
Eligibility Criteria
Inclusion
- Be willing and able to provide written informed consent for the trial.
- Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
- The inferior margin of the tumor ≤ 10 cm from the anal verge ;
- No prior anti-cancer treatment for rectal cancer;
- Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
- Adequate hematologic and end-organ function;
- Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
Exclusion
- Unresectable disease determined by investigators
- Recurrent rectal cancer
- Evidence of metastatic disease or lateral lymph node metastases
- Presence of synchronous colorectal cancer
- Presence of obstruction or imminent obstruction
- Not eligible for long-course radiotherapy
- Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
- Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical/breast cancer.
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT05300269
Start Date
July 5 2022
End Date
October 31 2026
Last Update
July 29 2022
Active Locations (1)
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1
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032