Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)
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: Long-course radiotherapy, Oxaliplatin, Capecitabine, Celecoxib.
- Who it may be relevant to
- Registry conditions: Locally Advanced Rectal Cancer, Neoadjuvant Therapy. 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 →
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Official title
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)
Overview
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.
Interventions
- Radiation Long-course radiotherapy
Long-course radiation: 50Gy/25Fx - Drug Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w - Drug Capecitabine
Xeloda - Drug Celecoxib
celecoxib 200 mg orally twice a day - Radiation Short-course radiotherapy
Short-course radiotherapy: 25Gy/5Fx - Drug Serplulimab
Serplulimab 300mg, d1, q3w
Primary outcome measures
- Complete response (CR) rate [Time frame: 1 month after the surgery or the decision of W&W]
Secondary outcome measures (6)
- Grade 3-4 adverse effects rate [Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy]
- 3 year anal preservation rate [Time frame: 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 [Time frame: 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 [Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.]
- 3 year overall survival rate [Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.]
- Rate of surgical complications [Time frame: The surgical complications were assessed within 3 months after the surgery.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
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 · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07150949 · FDRT-2025-254-4403