Actively Recruiting
SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2022-07-29
73
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
CONDITIONS
Official Title
SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial
- Diagnosed with locally advanced rectal adenocarcinoma evaluated as resectable
- Tumor's inferior margin is 10 cm or less from the anal verge
- No previous anti-cancer treatment for rectal cancer
- ECOG Performance Status of 0 or 1
- Adequate blood counts and organ function
- Using effective contraception from consent until 6 months after last study drug dose
You will not qualify if you...
- Disease that is determined to be unresectable by investigators
- Recurrent rectal cancer
- Evidence of metastatic disease or lateral lymph node metastases
- Presence of synchronous colorectal cancer
- Presence of obstruction or risk of obstruction
- Not eligible for long-course radiotherapy
- Severe cardiovascular or cerebrovascular disease with uncontrolled symptoms
- Prior malignancy within 5 years except certain treated skin or cervical/breast cancers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Q
Qing Yang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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