Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)
A Prospective Randomized Phase II Trial of Long-Course Chemoradiotherapy or Short-Course Radiotherapy Combined With CAPOX, PD-1 Antibody, and a COX-2 Inhibitor for Microsatellite Stable Locally Advanced Rectal Cancer (SERRAC)
1 other identifier
interventional
138
1 country
1
Brief Summary
SERRAC is a prospective, multicentre, randomized phase II trial. 138 LARC (T3-4/N+M0, distance from anal verge ≤10cm) patients will be treated with neoadjuvant therapy and assigned to Group A and Group B (1:1). Group 1 receives LCRT (50Gy/25Fx) followed by 3 cycles of CAPOX.Group 2 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. The COX2 inhibitor celecoxib 200 mg was started orally twice a day during chemotherapy until the end of neoadjuvant treatment.TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2025
CompletedStudy Start
First participant enrolled
August 28, 2025
CompletedFirst Posted
Study publicly available on registry
September 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
September 2, 2025
August 1, 2025
2 years
August 27, 2025
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response (CR) rate
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
1 month after the surgery or the decision of W&W
Secondary Outcomes (6)
Grade 3-4 adverse effects rate
From date of randomization until 3 months after the completion neoadjuvant therapy
3 year anal preservation rate
From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 36 months.
3 year disease free survival rate
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
3 year local recurrence free survival rate
From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
3 year overall survival rate
From date of randomization until the date of death from any cause, assessed up to 36 months.
- +1 more secondary outcomes
Study Arms (2)
Long-course Radiotherapy plus chemotherapy group
EXPERIMENTALShort-course Radiotherapy plus immunochemotherapy group
EXPERIMENTALInterventions
Long-course radiation: 50Gy/25Fx
Oxaliplatin: 130mg/m2 d1 q3w
Xeloda
celecoxib 200 mg orally twice a day
Short-course radiotherapy: 25Gy/5Fx
Serplulimab 300mg, d1, q3w
Eligibility Criteria
You may qualify if:
- Age 18-75 years, gender not limited
- Pathologically confirmed rectal adenocarcinoma
- ≤10 cm from the anus
- Baseline stage T3-4/N+
- No distant metastasis
- MSI/MMR status MSS/pMMR
- Karnofsky performance status score ≥70
- No prior chemotherapy or other anti-cancer treatment prior to enrollment
- No prior immunotherapy prior to enrollment
- Ability to comply with the study protocol
- Written informed consent
You may not qualify if:
- Pregnancy or breast-feeding women;
- Known history of other malignancies within 5 years;
- Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;
- Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
- Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
- Uncontrolled infection which needs systemic therapy;
- Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
- Allergic to any component of the therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhen Zhang, M.D, PH.D
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 27, 2025
First Posted
September 2, 2025
Study Start
August 28, 2025
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
September 2, 2025
Record last verified: 2025-08