Actively Recruiting
A Single-arm Phase II 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new combined treatment approach for patients with locally advanced low pMMR/MSS rectal cancer. This Phase II study aims to see if adding camrelizumab, an immunotherapy drug, to the standard long-course chemoradiotherapy (LCRT) can improve the rate of complete tumor response and potentially allow for organ preservation. This innovative treatment sequence involves chemo-immunotherapy both before and after radiation. Participants receive two cycles of camrelizumab combined with CAPOX chemotherapy, followed by long-course chemoradiotherapy consisting of a total radiation dose of 50.4 Gy given in 28 fractions along with concurrent oral capecitabine. Surgery is planned 4-6 weeks after the therapy, and pathological evaluation occurs within 1-2 weeks post-surgery. The study focuses on a single treatment group receiving this combination. During the study, doctors will assess complete response rates using imaging and endoscopy 4-6 weeks after therapy, and pathological response after surgery. Participants will undergo laboratory tests and clinical evaluations to monitor safety and treatment effects. The total participation lasts through neoadjuvant therapy and surgical assessment, aiming to improve treatment outcomes in this specific rectal cancer population.
CONDITIONS
Brief 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 18-75 years, male or female
- Histologically confirmed T3-4 and/or N+ rectal adenocarcinoma
- Tumor lower margin ≤10 cm from the anal verge
- Expected to achieve R0 resection
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 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 specified blood counts and organ function limits
- Fertile patients willing to use contraceptive measures during the trial
You will not qualify if you...
- Prior or current anti-tumor therapy for any cancer
- Known MSI-H or dMMR status
- Major surgery or severe trauma within 4 weeks before study drug
- Allergy or contraindication to camrelizumab or platinum agents
- Poorly controlled cardiac conditions including heart failure and arrhythmias
- Severe infection within 4 weeks before study drug or active pulmonary inflammation
- Active autoimmune diseases or history requiring medical intervention
- Immunodeficiency including HIV or active hepatitis B/C infection
- Use of immunosuppressive drugs within 14 days prior to study drug
- Known interstitial lung disease except imaging-only changes
- Another malignancy within 5 years except low-risk cancers
- Pregnant or breastfeeding women
- Other serious diseases or conditions affecting safety or compliance
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 9 weeks
Participants receive 2 cycles of camrelizumab combined with chemotherapy (CAPOX), followed by long-course chemoradiotherapy (LCRT).
Multiple visits during 2 cycles of camrelizumab with CAPOX and 28 fractions of chemoradiotherapy
Duration - Approximately 6 to 8 weeks
Participants undergo assessment of complete clinical response (cCR) by imaging and endoscopy 4-6 weeks after therapy, followed by surgery and pathology evaluation within 1-2 weeks after surgery.
1 visit for cCR assessment and surgery with pathology evaluation
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
G
Guanghai Dai, MD
X
Xiao Wang
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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