SCRT Combined With CAPOX and PD-1/CTLA4 Antibody for Early-stage Low Rectal Cancer

NCT07837362 | Not Yet Recruiting Phase 2

• 1 other identifier: FDRT-2026-306-5158
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the combination of immunotherapy of PD-1/ CTLA4 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1/ CTLA4 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

Conditions

Early Low Rectal Cancer

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.

  From date of receiving neoadjuvant therapy, assessed up to 2 years

Secondary Outcomes (6)

• Organ preservation rate

  From date of receiving neoadjuvant therapy, assessed up to 2 years

• 3 year disease free survival rate

  From date of initiation of treatment 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 initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.

• 3 year overall survival rate

  From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.

• 10 year Quality of Life

  From date of initiation of treatment until the date of death from any cause, assessed up to 10 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1/CTLA4 antibody, finally receive the TEM or TME surgery.

Radiation: Shor-course radiotherapy; Drug: PD-1/CTLA4 Antibody; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Shor-course radiotherapy RADIATION

Shor-course radiotherapy: 25Gy/5Fx

Treatment Arm

Capecitabine DRUG

Capecitabine: 1000mg/m2 d1-14 q3w

Treatment Arm

PD-1/CTLA4 Antibody DRUG

Iparomlimab and Tuvonralimab, 5mg/kg, d1 q3w

Treatment Arm

Oxaliplatin DRUG

130mg/m2 d1 q3w

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75 years old, female and male
• pathological confirmed adenocarcinoma
• clinical stage T1-3bN0, tumor maximum diameter less than 4cm
• the distance from anal verge less than 5 cm
• without distance metastases
• KPS \>=70
• with good compliance
• microsatellite repair status is MSS/pMMR
• without previous anti-cancer therapy or immunotherapy
• signed the inform consent

You may not qualify if:

• pregnancy or breast-feeding women
• pathological confirmed signet ring cell carcinoma
• clinical stage T1N0 and can be resected locally
• history of other malignancies within 5 years
• serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
• immunodeficiency disease or long-term using of immunosuppressive agents
• baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
• DPD deficiency
• allergic to any component of the therapy

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Interventions

Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Central Study Contacts

Zhen Zhang, M.D, PH.D

CONTACT

18801735029; zhen_zhang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (1)