Actively Recruiting
A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer
Led by Chinese PLA General Hospital · Updated on 2026-04-14
44
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In pMMR/MSS locally advanced rectal cancer, can the innovative "chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation" approach significantly improve the complete response rate and create opportunities for organ preservation?
CONDITIONS
Official Title
A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Histologically confirmed T3-4 and/or N+ rectal adenocarcinoma
- Tumor lower margin 10 cm or less from the anal verge
- Expected to achieve complete surgical removal (R0 resection)
- ECOG performance status of 0 or 1
- Able to swallow tablets normally
- No prior anti-tumor therapy for rectal cancer
- Planned surgical treatment after neoadjuvant therapy
- No contraindications to surgery
- Laboratory tests meeting specific blood counts and organ function levels
- Fertile patients willing to use contraception during the trial
You will not qualify if you...
- Prior or current anti-tumor therapy for any cancer
- Known MSI-high or deficient mismatch repair status
- Major surgery or severe trauma within 4 weeks before starting study drug
- Allergies or contraindications to camrelizumab or platinum-based drugs
- Poorly controlled heart conditions including heart failure NYHA class II or higher, unstable angina, recent myocardial infarction, or significant arrhythmias
- Severe infection within 4 weeks before starting study drug or signs of active infection
- Active or history of autoimmune diseases requiring treatment, except certain stable or resolved conditions
- Immunodeficiency including HIV or active hepatitis B or C infections
- Use of immunosuppressive drugs within 14 days before study drug except certain corticosteroids
- Known interstitial lung disease
- Diagnosis of another malignancy within 5 years except low-risk cancers
- Pregnant or breastfeeding women
- Any other conditions or factors that may risk patient safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
G
Guanghai Dai, MD
CONTACT
X
Xiao Wang
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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