Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
NCT ID: NCT07154316
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
138 participants
INTERVENTIONAL
2025-08-01
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Long-course chemoradiotherapy group
The long-course chemoradiotherapy (LC-CRT) arm refers to a preoperative treatment regimen combining normofractionated radiotherapy with concurrent chemotherapy.
LCRT
50Gy/25Fx
CAPOX
1000mg/m2 bid d1-14
PD-1
300mg d1，q3w
Celecoxib
200mg, bid
Short-course chemoradiotherapy group
The short-course chemoradiotherapy group refers to a preoperative regimen combining hypofractionated radiotherapy with concurrent or sequential chemotherapy .
SCRT
25Gy/5Fx
CAPOX
1000mg/m2 bid d1-14
PD-1
300mg d1，q3w
Celecoxib
200mg, bid
Interventions
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LCRT
50Gy/25Fx
SCRT
25Gy/5Fx
CAPOX
1000mg/m2 bid d1-14
PD-1
300mg d1，q3w
Celecoxib
200mg, bid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Anyang Tumor Hospital
OTHER
Fujian Cancer Hospital
OTHER_GOV
Shandong First Medical University
OTHER
Yunnan Cancer Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Li Dawei
PhD
Locations
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Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Anyang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Yunnan Cancer Hospital
Kunming, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Shen Guan
Role: primary
Yanjun Wang
Role: primary
Jingbo Chen
Role: primary
Xinyi Cai
Role: primary
Other Identifiers
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SERRAC
Identifier Type: -
Identifier Source: org_study_id
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