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

September 17, 2026 updated by: Zhen Zhang, Fudan University

The Combination of PD-1/CTLA4 Antibody and Neoadjuvant Short-course Radiotherapy in Early-stage Low Rectal Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. pregnancy or breast-feeding women
  2. pathological confirmed signet ring cell carcinoma
  3. clinical stage T1N0 and can be resected locally
  4. history of other malignancies within 5 years
  5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
  6. immunodeficiency disease or long-term using of immunosuppressive agents
  7. 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
  8. DPD deficiency
  9. allergic to any component of the therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm

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

Shor-course radiotherapy: 25Gy/5Fx

Drug: PD-1/CTLA4 Antibody

Iparomlimab and Tuvonralimab, 5mg/kg, d1 q3w

Drug: Capecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

Drug: Oxaliplatin

130mg/m2 d1 q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response (CR) rate
Time Frame: From date of receiving neoadjuvant therapy, assessed up to 2 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ preservation rate
Time Frame: From date of receiving neoadjuvant therapy, assessed up to 2 years

Rate of patients who underwent organ preservation via WW or TEM after neoadjuvant therapy
From date of receiving neoadjuvant therapy, assessed up to 2 years
3 year disease free survival rate
Time Frame: 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

Rate of 3 year disease free survival
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
Time Frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.

Rate of 3 year local recurrence free survival
From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
3 year overall survival rate
Time Frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.

Rate of 3 year overall survival
From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
10 year Quality of Life
Time Frame: From date of initiation of treatment until the date of death from any cause, assessed up to 10 years

Patient self-assessment via EORTC QLQ-C30 questionnaire to monitor changes in quality of life throughout treatment.
From date of initiation of treatment until the date of death from any cause, assessed up to 10 years
Grade 3-4 adverse effects rate
Time Frame: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years

Incidence and severity of treatment side effects graded by NCI CTCAE v5.0.
From date of initiation of treatment until the date of death from any cause, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 23, 2026

First Submitted That Met QC Criteria

September 17, 2026

First Posted (Actual)

September 23, 2026

Study Record Updates

Last Update Posted (Actual)

September 23, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-2026-306-5158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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