A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QL1706, CAPEOX/Capecitabine.
- Who it may be relevant to
- Registry conditions: Colon Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug QL1706
Phase Ib/Ⅲ： QL1706 will be administered - Drug CAPEOX/Capecitabine
Phase Ⅲ：CAPEOX/Capecitabine will be administered
Primary outcome measures
- 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. [Time frame: 1 month after surgery]
- Event Free Survival, EFS(EFS), defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery. [Time frame: Up to approximately 5 years]
Secondary outcome measures (3)
- Overall Survival (OS) [Time frame: Up to approximately 5 years]
- R0 tumor resection rate [Time frame: 2 week after surgery]
- Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment [Time frame: Up to approximately 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Cancer Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06686576 · QL1706-307