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RecruitingNCT06281405TORCH-iTNTUpdated Apr 3, 2026

CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer

A Phase 2 interventional study of PD-1 inhibitor and Capecitabine in Locally Advanced Rectal Cancer and Neoadjuvant Therapy, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. 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, organ or anal preservation rate, 3-year DFS rate, etc.

02

Conditions studied

  • Locally Advanced Rectal Cancer
  • Neoadjuvant Therapy
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-70 years old, female and male;
  2. Pathological confirmed adenocarcinoma;
  3. The distance from anal verge ≤ 10 cm;
  4. MSI/MMR status: MSS/pMMR;
  5. Clinical stage T3-4 and/or N+, without distance metastases;
  6. At least one of the following factors is present: distance from the anus ≤5 cm, cT4, cN2, positive cMRF, positive cEMVI, or positive lateral lymph nodes;
  7. KPS ≥ 70;
  8. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
  9. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;
  10. With good compliance and signed the consent form.

Exclusion criteria

Exclusion Criteria

  1. Pregnancy or breast-feeding women;
  2. Known history of other malignancies within 5 years;
  3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
  4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
  5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
  6. Uncontrolled infection which needs systemic therapy;
  7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
  8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;
  9. Allergic to any component of the therapy.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    Immunochemotherapy group

    The patients will receive 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\&W option can be applied to patients achieving cCR.

    Drug: PD-1 inhibitor · Drug: Capecitabine · Drug: Oxaliplatin

  • Experimental
    Radiation plus immunochemotherapy group

    The patients will receive short-course radiotherapy (25Gy/5Fx), followed by 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT while a W\&W option can be applied to patients achieving cCR.

    Drug: PD-1 inhibitor · Drug: Capecitabine · Radiation: Short-course radiotherapy · Drug: Oxaliplatin

Interventions

  • DrugPD-1 inhibitor

    PD-1 inhibitor (Toripalimab): 240mg d1 q3w

    Also known as: Toripalimab

  • DrugCapecitabine

    Capecitabine: 1000mg/m2 bid d1-14 q3w

  • RadiationShort-course radiotherapy

    Short-course radiotherapy: 25Gy/5Fx

  • DrugOxaliplatin

    Oxaliplatin 130mg/m2 d1 q3w

06

What researchers measure

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.

    Time frame: 1 month after the surgery or the decision of W&W

Secondary outcomes

  1. Grade 3-4 adverse effects rate

    Rate of chemotherapy, radiotherapy and immunotherapy related adverse events

    Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy

  2. 3 year organ or anal preservation rate

    3 year organ or anal preservation rate

    Time frame: From date of randomization until the resection of rectum or anus, assessed up to 36 months.

  3. 3 year disease free survival rate

    Rate of 3 year disease free survival

    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.

  4. 3 year local recurrence free survival rate

    Rate of 3 year local recurrence free survival

    Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.

  5. 3 year distant metastasis free survival rate

    Rate of 3 year distant metastasis free survival

    Time frame: From date of randomization until the date of first documented distant metastasis, assessed up to 36 months.

  6. 3 year overall survival rate

    Rate of 3 year overall survival

    Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.

  7. Rate of surgical complications

    Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.

    Time frame: The surgical complications were assessed within 3 months after the surgery.

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06281405
Lead sponsor
Fudan University
Responsible party
Zhen Zhang (Study Principal Investigator, Fudan University) — Principal investigator
First posted
Feb 28, 2024
Start date
Mar 28, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 3, 2026

Study contacts

Zhen Zhang, MD
Contact
zhen_zhang@fudan.edu.cn
18801735029
Yaqi Wang, MD
Contact
10301010093@fudan.edu.cn
18121299593
Zhen Zhang, MD
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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