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Recruiting NCT07154316

Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer

Phase II Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LCRT, SCRT, CAPOX, PD-1.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation LCRT
    50Gy/25Fx
  • Radiation SCRT
    25Gy/5Fx
  • Drug CAPOX
    1000mg/m2 bid d1-14
  • Drug PD-1
    300mg d1，q3w
  • Drug Celecoxib
    200mg, bid

Primary outcome measures

  • CR (Complete Response) [Time frame: 3 years]
Secondary outcome measures (6)
  • sphincter preservation rate [Time frame: 3 years]
  • Grade 3 or higher toxicity rate [Time frame: 3 years]
  • 3yPFS (Progression-Free Survival) [Time frame: 3 years]
  • 3yLRFS (Local Recurrence-Free Survival) [Time frame: 3 years]
  • 3yOS (Overall Survival) [Time frame: 3 years]
  • Surgical complications [Time frame: 3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • Fujian Provincial Cancer Hospital — Fuzhou
  • Anyang Tumor Hospital — Anyang
  • The First Affiliated Hospital of Shandong First Medical University — Jinan
  • Yunnan Cancer Hospital — Kunming
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07154316 · SERRAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗