NCT07154316RecruitingPhase 2
Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
A Randomized Phase II Study of Long-term Chemoradiotherapy or Short-term Radiotherapy Combined With CAPOX, PD-1 Monoclonal Antibody and COX-2 Inhibitors in MSS Type Locally Advanced Rectal Cancer
Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This randomized phase II trial evaluates the efficacy of long-course chemoradiotherapy (50Gy/25Fx + capecitabine) versus short-course radiotherapy (25Gy/5Fx) combined with CAPOX（Capecitabine and Oxaliplatin）, PD-1 inhibitor (serplulimab), and COX-2 inhibitor (celecoxib) in MSS（MicroSatellite Stable） locally advanced rectal cancer, with primary endpoint of complete response rate (pCR+cCR)（Complete Remission） and secondary endpoints including anal preservation rate and 3-year survival outcomes, aiming to elucidate the immunomodulatory effects of triple therapy on tumor microenvironment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT07154316
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 138
- From 1 Aug 2025 to the primary completion date, 1 Aug 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals requiring immunosuppressive therapy for organ transplantation and those on long-term corticosteroid therapy.
- Individuals with severe, uncontrolled, recurrent infections or other severe, uncontrolled concurrent diseases.
Other illness
- Individuals with a history of other malignant diseases within the past 5 years, excluding cured skin cancer and cervical carcinoma in situ.
- Individuals with a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, where the clinical severity (as judged by the investigator) may impair the ability to sign the informed consent form or affect compliance with oral medication.
- Clinically significant (i.e., active) heart disease, including symptomatic coronary heart disease, congestive heart failure of New York Heart Association (NYHA) class II or worse, severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the past 12 months.
- Individuals with autoimmune diseases.
- Individuals with known dihydropyrimidine dehydrogenase (DPD) deficiency. Individuals with a history of hypersensitivity to any component of the study medications.
Lab values
- Baseline blood routine and biochemical parameters not meeting the following criteria: hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelets ≥100×10⁹/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN); alkaline phosphatase (ALP) ≤2.5×ULN; serum total bilirubin \<1.5×ULN; serum creatinine \<1×ULN; serum albumin ≥30 g/L.
Other
- Pregnant or lactating women.
Who the study is looking for
- Age 18-75 years, regardless of gender.
- Pathologically confirmed rectal adenocarcinoma.
- Tumor located ≤10 cm from the anal verge.
- Baseline stage T3-4 and/or N+ (locally advanced disease).
- No evidence of distant metastasis.
- Microsatellite stability (MSS) or proficient mismatch repair (pMMR).
- Karnofsky Performance Status (KPS) ≥70.
- No prior chemotherapy or any other anticancer therapy before enrollment.
- No prior immunotherapy.
- Able to comply with study protocol requirements throughout the study period.
- Signed written informed consent obtained prior to study participation.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang Tumor Hospital Coordinator of this site? Confirm its status | Anyang | China | Recruiting |
| Fujian Provincial Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The First Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.