NCT05628038: TORCH-R

The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

Recruiting now Phase 2 Last updated 1 October 2024

What this trial tests

Phase 2 trial testing PD-1 antibody in Recurrent Rectal Cancer in 93 participants. Currently enrolling.

Timeline

30 November 2022

Primary endpoint
1 December 2024

1 December 2025

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	93
Start date	30 November 2022
Primary completion	1 December 2024
Estimated completion	1 December 2025
Sites	1 location across China

Drugs / interventions tested

• PD-1 antibody
• Capecitabine (capecitabine) — full drug profile →
• 5FU
• folinic acid — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Irinotecan
• Raltitrexed (RALTITREXED) — full drug profile →
• Cetuximab
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Radiation

Conditions studied

• Recurrent Rectal Cancer — all drugs for Recurrent Rectal Cancer →

Sponsor

Fudan University

Who can join

Adults 18 to 75, any sex, with Recurrent Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy +/- target therapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit.

The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment.

Shanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy during the Immediate Perioperative Period: A Promising Approach against Metastatic Disease.
   Sandbank E, Eckerling A, Margalit A, Sorski L, et al · · 2023 · cited 10× · PMID 37623021 · DOI 10.3390/curroncol30080540
2. TORCH-R trial protocol: hypofractionated radiotherapy combined with chemotherapy and toripalimab for locally recurrent rectal cancer: a prospective, single-arm, two-cohort, phase II trial.
   Wan J, Wu R, Fu M, Shen L, et al · · 2023 · cited 3× · PMID 38053659 · DOI 10.3389/fonc.2023.1304767
3. Pelvic stereotactic ablative body radiotherapy (SABR) reirradiation: UK SABR consortium guidance for use in routine clinical care.
   Moreno-Olmedo E, Owczarczyk K, Chadwick E, Dickinson P, et al · · 2025 · cited 2× · PMID 40822090 · DOI 10.1016/j.tipsro.2025.100326
4. Combination immunotherapy for colorectal cancer: Clinical applications, rationale, challenges, and future perspectives.
   Fei J, Cai C, Wu W, Shen H, et al · · 2026 · PMID 41950929 · DOI 10.1016/j.xcrm.2026.102728
5. Hypofractionated radiotherapy combined with chemotherapy and Toripalimab for locally recurrent rectal cancer: a single-arm, phase II trial (TORCH-R)
   Wu R, Shen L, Zhang H, Wang Y, et al · · 2023 · DOI 10.21203/rs.3.rs-2321383/v1