Clinical trial · Interventional
Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer
A Single-arm, Prospective, Phase II Clinical Study of Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Low-middle Rectal Cancer with a High Risk of Recurrence
NCT06760520CI-TRIAL-00084432not 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 is a single-arm, prospective, phase II clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with ivonescimab and chemotherapy + total mesorectal excision(TME) surgery in patients with 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 |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ivonescimab (SMT112 or AK112) Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ivonescimab+chemotherapy
- description
- Local advanced rectal cancer with short-course radiotherapy followed by sequential chemotherapy and ivonescimab
- interventionNames
- Drug: Ivonescimab (SMT112 or AK112) Injection
Primary outcomes (1)
- measure
- Complete response rate (CR, pCR plus cCR )
- timeFrame
- pCR rate : within 1 week after surgery；cCR：12-13 weeks after radiotherapy ends
- description
- pathological complete response rate plus clinical complete response rate
Secondary outcomes (7)
- measure
- 3-years DFS rate
- timeFrame
- From date of treatment until the date of first documented disease relapse or date of death from any cause, whichever came first about 3years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG score of 0-1; * histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis * Tumor distance from anal verge ≦10cm * at least one high-risk criterion defined by pelvic MRI: cT stage \>T2 (tumor invades intrinsic muscularis propria by more than 5 mm); Extramural vascular invasion; cN2; Involvement of the rectal mesorectal fascia (tumor or lymph node ≤1mm from the rectal mesorectal fascia); Lateral lymph node short diameter ≥5mm * enough organ function Exclusion Criteria: * with known MSI-H or dMMR * Multiple primary adenocarcinomas * History of pelvic radiotherapy * Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immunocellular therapy, and other treatments targeting the immune mechanism of the tumor.
References
Publications (0)
Data not yet available
No reference posted for this study.