Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
Recruiting
Phase 2
Interventional Study
Colorectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 138 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
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 …
Trial Locations
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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 …
Contacts