Actively Recruiting
Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Led by Hong Qiu · Updated on 2026-03-17
48
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC. Participants will take: Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
CONDITIONS
Official Title
Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and voluntary participation
- Age between 18 and 75 years
- Pathologically confirmed rectal adenocarcinoma meeting criteria such as cT3-4, cN2, EMVI+, or MRF+
- pMMR or MSS/MSI-L rectal adenocarcinoma
- Tumor edge distance to anal verge specified
- Expected to complete R0 resection
- Ability to swallow pills
- ECOG performance status 0-1
- No prior anti-tumor treatments including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Plan to complete surgery after neoadjuvant therapy
- No contraindication to surgery
- Adequate main organ function including blood tests and coagulation
- Female participants with reproductive capacity must have a negative pregnancy test within 72 hours before starting treatment and use effective contraception during and for 3 months after the study; male participants with partners of reproductive potential must also use effective contraception during and 3 months after treatment
You will not qualify if you...
- Allergy to monoclonal antibodies, SHR-1701, capecitabine, oxaliplatin, or other platinum drugs
- Previous or current treatments including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Use of immunosuppressive or systemic steroid drugs above specified doses within 2 weeks before study drug
- Receipt of live attenuated vaccines within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Active autoimmune diseases or history of autoimmune diseases requiring intervention
- History of immunodeficiency, HIV positive, or organ/bone marrow transplantation
- Uncontrolled heart diseases including heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Severe infections requiring hospitalization or active pulmonary infections within specified periods
- Active tuberculosis infection or recent history without proper treatment
- Active hepatitis B or C infection above specified viral load limits
- Diagnosis of other malignant tumors within 5 years except low risk cancers
- Pregnant or breastfeeding women
- Other serious illnesses, mental disorders, substance abuse, or social factors affecting safety or compliance as judged by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Q
Qiu Hong
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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