A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Colon Cancer

Treatments: Drug: CAPEOX/Capecitabine; Drug: QL1706

Study type: Interventional

Funder types: Industry

Identifiers

NCT06686576

QL1706-307

Details and patient eligibility

About

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

Enrollment: 363 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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363 participants in 2 patient groups

Experimental group

Experimental group

Description:

Phase Ib/Ⅲ Participants will receive QL1706 pre surgery

Treatment:

Drug: QL1706

Phase III Control group

Active Comparator group

Description:

Participants will receive SOC (CAPEOX/Capecitabine) or undergo expectant observation post surgery.

Treatment:

Drug: CAPEOX/Capecitabine