A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer
NCT ID: NCT06686576
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
363 participants
INTERVENTIONAL
2024-12-12
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
Phase Ib/Ⅲ Participants will receive QL1706 pre surgery
QL1706
Phase Ib/Ⅲ： QL1706 will be administered
Phase III Control group
Participants will receive SOC (CAPEOX/Capecitabine) or undergo expectant observation post surgery.
CAPEOX/Capecitabine
Phase Ⅲ：CAPEOX/Capecitabine will be administered
Interventions
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QL1706
Phase Ib/Ⅲ： QL1706 will be administered
CAPEOX/Capecitabine
Phase Ⅲ：CAPEOX/Capecitabine will be administered
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Affiliated Cancer Hospital of Sun Yat-sen University
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Rui hua Xu, PhD
Role: primary
Other Identifiers
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QL1706-307
Identifier Type: -
Identifier Source: org_study_id