Clinical trial · Interventional
The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer
A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
- 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 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 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
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 |
|---|---|---|---|
| Early Low Rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| PD-1 antibody | Drug | — | UNRESOLVED |
| Short-course radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TEM or TME surgery.
- interventionNames
- Drug: PD-1 antibody
- Drug: Capecitabine
- Drug: Oxaliplatin
- Radiation: Short-course radiotherapy
Primary outcomes (1)
- measure
- complete response (CR) rate
- timeFrame
- The status of cCR will be evaluated after the completion of neoadjuvant therapy. The pCR rate will be evaluated after surgery. The cCR patients who adopted W&W strategy will be included into the CR rate caluculation.
- description
- Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W\&W strategy.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. age 18-70 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
References
Publications (1)
- DERIVEDChen Y, Wang Y, Zhang H, Wan J, Shen L, Wang Y, Zhou M, Wu R, Yang W, Zhou S, Cai S, Li X, Zhang Z, Xia F. Short-course radiotherapy combined with chemotherapy and PD-1 inhibitor in low-lying early rectal cancer: study protocol for a single-arm, multicentre, prospective, phase II trial (TORCH-E). BMJ Open. 2023 Oct 6;13(10):e076048. doi: 10.1136/bmjopen-2023-076048. PMID 37802608