Colorectal Cancer
Conditions
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.
Interventions
Sponsors
Anyang Tumor Hospital
Fujian Cancer Hospital
Shandong First Medical University
Yunnan Cancer Hospital
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR (Complete Response) | 3 years | Complete response (CR) in malignant tumor patients is defined as the complete disappearance of all target lesions, normalization of tumor marker levels, and absence of new lesions for ≥4 weeks after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade 3 or higher toxicity rate | 3 years | — |
| 3yPFS (Progression-Free Survival) | 3 years | PFS (Progression-Free Survival) in oncology is defined as the time from the initiation of treatment to the occurrence of disease progression or death from any cause , whichever occurs first. |
| sphincter preservation rate | 3 years | — |
| 3yOS (Overall Survival) | 3 years | Measures the time until death , regardless of cause, reflecting the ultimate therapeutic outcome . |
| Surgical complications | 3 years | — |
| 3yLRFS (Local Recurrence-Free Survival) | 3 years | LRFS (Local Recurrence-Free Survival) is a clinical endpoint in oncology that measures the time from treatment initiation to the occurrence of local recurrence or death from any cause , whichever occurs first, commonly used to assess tumor control efficacy after surgery or radiotherapy. |
Countries
China
Contacts
Primary ContactDawei Li
Outcome results
None listed