NCT07154316 Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
| NCT ID | NCT07154316 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 138 participants in total. It began in 2025-08-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant or lactating women. * 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 requiring immunosuppressive therapy for organ transplantation and those on long-term corticosteroid therapy. * Individuals with autoimmune diseases. * Individuals with severe, uncontrolled, recurrent infections or other severe, uncontrolled concurrent diseases. * 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. * Individuals with known dihydropyrimidine dehydrogenase (DPD) deficiency. Individuals with a history of hypersensitivity to any component of the study medications.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07154316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07154316 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07154316 currently recruiting?
Yes, NCT07154316 is actively recruiting participants. Contact the research team at li_dawei@fudan.edu.cn for enrollment information.
Where is the NCT07154316 trial being conducted?
This trial is being conducted at Fuzhou, China, Anyang, China, Jinan, China, Kunming, China and 1 additional location.
Who is sponsoring the NCT07154316 clinical trial?
NCT07154316 is sponsored by Fudan University. The trial plans to enroll 138 participants.
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