Clinical trial · Interventional
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer
A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Instability-High Locally Advanced 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 addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC). A total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis 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 Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Neoadjuvant Radiotherapy | Radiation | — | UNRESOLVED |
| PD-1 antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- A total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX.
- interventionNames
- Drug: PD-1 antibody
- Drug: Capecitabine
- Drug: Irinotecan
- Radiation: Neoadjuvant Radiotherapy
Primary outcomes (1)
- measure
- Pathologic Complete Response Rate
- timeFrame
- The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy.
- description
- Pathologic Complete Response Rate
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathological confirmed adenocarcinoma 2. clinical stage T3-4 and/or N+ 3. the distance from anal verge less than 12 cm 4. without distance metastases 5. age 18-70 years old, female and male 6. KPS \>=70 7. UGT1A1\*28 6/6 or 6/7 8. the MSI status is MSI-H or d-MMR 9. without previous anti-cancer therapy or immunotherapy 10. with good compliance 11. 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. DPD deficiency 7. UGT1A1\*28 7/7 8. the MSI status is MSS or p-MMR 9. allergic to any component of the therapy
References
Publications (0)
Data not yet available