Clinical trial · Interventional
A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer
A Phase Ib/III, Open-Label, Randomized Study of Neoadjuvant QL1706 Versus Standard of Care in Participants With Untreated of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
NCT06686576CI-TRIAL-00099258recruitingPhase 3ClinicalTrials.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)
The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon 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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAPEOX/Capecitabine | Drug | — | UNRESOLVED |
| QL1706 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Phase Ib/Ⅲ Participants will receive QL1706 pre surgery
- interventionNames
- Drug: QL1706
- type
- ACTIVE_COMPARATOR
- label
- Phase III Control group
- description
- Participants will receive SOC (CAPEOX/Capecitabine) or undergo expectant observation post surgery.
- interventionNames
- Drug: CAPEOX/Capecitabine
Primary outcomes (2)
- measure
- Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent; * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Untreated pathologically confirmed colon adenocarcinoma * Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only). * Has a tumor demonstrating the presence of MSI-H/ dMMR * Adequate organ function as described in the protocol Exclusion Criteria: * Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc * Has distant metastatic disease. * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has know history of, or any evidence of interstitial lung disease; * Has an active infection requiring systemic therapy
References
Publications (0)
Data not yet available
No reference posted for this study.