Clinical trial · Interventional
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk PMMR/MSS Locally Advanced Rectal Cancer: a Prospective, Exploratory Phase II Trial（iMHRT-LARC）
NCT06599827CI-TRIAL-00080846iMHRT-LARCnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to evaluate the effectiveness and safety of combining moderately hypofractionated radiotherapy with chemotherapy and anti-PD-1 antibodies as a neoadjuvant treatment for high-risk locally advanced rectal cancer.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| immunotherapy | Drug | Immunotherapy | ALIAS |
| moderately hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Total mesorectal excision (TME) surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- This study examines combined radiotherapy, chemotherapy, and immunotherapy for high-risk locally advanced rectal cancer. After a week post-radiotherapy, patients start CapeOx chemotherapy with anti-PD-1 mAb. Surgery follows after 3 cycles of this regimen.
- interventionNames
- Radiation: moderately hypofractionated radiotherapy
- Drug: chemotherapy
- Drug: immunotherapy
- Procedure: Total mesorectal excision (TME) surgery
Primary outcomes (1)
- measure
- pathologic complete response (pCR)
- timeFrame
- 30-day
- description
- Proportion of patients in whom no cancer cells are found in resected rectal tissue and regional lymph nodes upon pathological evaluation.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 and ≤75 years. 2. MRI-confirmed rectal adenocarcinoma with the lower edge of the lesion ≤10cm from the anal verge. 3. Immunohistochemistry confirms proficiency in DNA mismatch repair (pMMR), or genetic testing confirms microsatellite instability-low (MSI-L) or microsatellite stable (MSS) status. 4. Pelvic MRI showing one of the following high-risk factors: cT4a/b; N2; extramural vascular invasion (EMVI+); mesorectal fascia involvement (MRF+); enlarged lateral lymph nodes. 5. ECOG performance status of 0-1. 6. No prior surgery, radiotherapy, chemotherapy, or targeted therapy. 7. Tolerable to radiotherapy, chemotherapy, and immunotherapy with laboratory results: WBC ≥4.0 × 10\^9/L, platelets ≥100 × 10\^9/L, hemoglobin ≥80g/L, ALT \<2ULN, TB \<35μmol/L, Scr \<1.5ULN or creatinine clearance rate ≥50mL/min, TSH ≤ULN (if abnormal, consider T3 and T4 levels; if T3 and T4 are normal, patients can still be included). 8. Voluntary participation with signed informed consent. Exclusion Criteria: 1. Distant metastases. 2. Stage I or II rectal cancer not requiring neoadjuvant therapy. 3. Severe cardiovascular, pulmonary, neurological, renal, gastrointestinal, or systemic diseases. 4. Untreated chronic hepatitis B carrier with HBV DNA \>500 IU/ml, HCV RNA positive patients, except for inactive hepatitis B surface antigen carriers, stable hepatitis B (HBV DNA \<500 IU/ml), and cured hepatitis C patients. 5. History of active autoimmune diseases or potential relapse of autoimmune diseases. 6. Patients who received corticosteroids (equivalent to prednisone \>10mg/day) or other immunosuppressive therapy within 2 weeks prior to study drug administration. 7. History of thyroid dysfunction. 8. Severe chronic or active infections requiring systemic antifungal or antiviral therapy, including tuberculosis. 9. Known allergy or hypersensitivity to multiple drugs. 10. History of pelvic radiation. 11. History of inflammatory bowel disease. 12. Unwillingness to participate or sign informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.