Clinical trial · Interventional
Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)
Short-course Radiotherapy Combined With CAPOX and Pd-1 Inhibitor for Locally Advanced Colon Cancer: a Randomized, Prospective, Multicentre, Phase II Trial (TORCH-C)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response （pCR）, long-term prognosis and adverse effects will be analyzed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Serplulimab | Drug | Serplulimab | ALIAS |
| short-term radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- short-course radiotherapy and immunotherapy
- description
- A total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.
- interventionNames
- Drug: Serplulimab
- Radiation: short-term radiotherapy
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- description
- A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathological confirmed adenocarcinoma 2. clinical stage T4 and/or bulky nodes 3. the distance from anal verge more than 15 cm 4. without distance metastases 5. age \>=18 years old, female and male 6. KPS \>=70 7. without previous anti-cancer therapy or immunotherapy 8. with good compliance 9. signed the inform consent Exclusion Criteria: 1. pregnancy or breast-feeding women 2. history of other malignancies within 5 years 3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 4. immunodeficiency disease or long-term using of immunosuppressive agents 5. 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 6. allergic to any component of the therapy
References
Publications (1)
- DERIVEDZhang H, Li Y, Xia F, Sun Y, Shen L, Wan J, Chen Y, Wang Y, Zhou M, Wu R, Zhou S, Wang Y, Liu F, Cai S, Zhang Z. Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomised, prospective, multicentre, phase II trial (TORCH-C). BMJ Open. 2024 Feb 2;14(2):e079442. doi: 10.1136/bmjopen-2023-079442. PMID 38309748