RecruitingPhase 2NCT07150949

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)


Sponsor

Fudan University

Enrollment

138 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria11

  • 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 Criteria10

  • 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.

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Interventions

RADIATIONLong-course radiotherapy

Long-course radiation: 50Gy/25Fx

DRUGOxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

DRUGCapecitabine

Xeloda

DRUGCelecoxib

celecoxib 200 mg orally twice a day

RADIATIONShort-course radiotherapy

Short-course radiotherapy: 25Gy/5Fx

DRUGSerplulimab

Serplulimab 300mg, d1, q3w


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07150949


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