Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

NCT ID: NCT07150949

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-28
• Study Completion Date: 2028-08-31

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.

Conditions

Locally Advanced Rectal Cancer; Neoadjuvant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Long-course Radiotherapy plus chemotherapy group

Group Type: EXPERIMENTAL

Long-course radiotherapy

Intervention Type: RADIATION

Long-course radiation: 50Gy/25Fx

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin: 130mg/m2 d1 q3w

Capecitabine

Intervention Type: DRUG

Xeloda

Celecoxib

Intervention Type: DRUG

celecoxib 200 mg orally twice a day

Serplulimab

Intervention Type: DRUG

Serplulimab 300mg, d1, q3w

Short-course Radiotherapy plus immunochemotherapy group

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin: 130mg/m2 d1 q3w

Capecitabine

Intervention Type: DRUG

Xeloda

Celecoxib

Intervention Type: DRUG

celecoxib 200 mg orally twice a day

Short-course radiotherapy

Intervention Type: RADIATION

Short-course radiotherapy: 25Gy/5Fx

Serplulimab

Intervention Type: DRUG

Serplulimab 300mg, d1, q3w

Interventions

Long-course radiotherapy

Long-course radiation: 50Gy/25Fx

Intervention Type: RADIATION

Oxaliplatin

Oxaliplatin: 130mg/m2 d1 q3w

Intervention Type: DRUG

Capecitabine

Xeloda

Intervention Type: DRUG

Celecoxib

celecoxib 200 mg orally twice a day

Intervention Type: DRUG

Short-course radiotherapy

Short-course radiotherapy: 25Gy/5Fx

Intervention Type: RADIATION

Serplulimab

Serplulimab 300mg, d1, q3w

Intervention Type: DRUG

Other Intervention Names

LCRT; SCRT

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years, gender not limited

2. Pathologically confirmed rectal adenocarcinoma

3. ≤10 cm from the anus

4. Baseline stage T3-4/N+

5. No distant metastasis

6. MSI/MMR status MSS/pMMR

7. Karnofsky performance status score ≥70

8. No prior chemotherapy or other anti-cancer treatment prior to enrollment

9. No prior immunotherapy prior to enrollment

10. Ability to comply with the study protocol

11. Written informed consent

Exclusion Criteria

1. Pregnancy or breast-feeding women;

2. Known history of other malignancies within 5 years;

3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc;

4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);

5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;

6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;

7. Uncontrolled infection which needs systemic therapy;

8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;

9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection

10. Allergic to any component of the therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Zhang, M.D, PH.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhen Zhang, M.D, PH.D

Role: CONTACT

zhen_zhang@fudan.edu.cn

18801735029

Yajie Chen, PH.D

Role: CONTACT

16111230008@fudan.edu.cn

18917239680

Facility Contacts

Zhang Zhen, MD PhD

Role: primary

zhen_zhang@fudan.edu.cn

+86 18017312217

Other Identifiers

FDRT-2025-254-4403

Identifier Type: -

Identifier Source: org_study_id