QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer

NCT ID: NCT07156682

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2028-06-30

Brief Summary

This is a single-arm, exploratory study enrolling participants with resectable stage III pMMR/MSS colon cancer. Eligible participants who provide written informed consent will receive four cycles of neoadjuvant treatment with iparomlimab and tuvonralimab (QL1706) plus XELOX regimen administered every three weeks (Q3W), followed by radical surgery within two weeks after the last neoadjuvant treatment. After surgery, participants will enter the follow-up phase, or clinicians may decide to administer four additional cycles of adjuvant XELOX chemotherapy based on postoperative pathological findings. The primary endpoint of this study is the pathological complete response (pCR) rate as assessed by investigators. Other endpoints include pathological response (PR), major pathological response (MPR), clinical complete response (cCR), event-free survival (EFS), overall survival (OS), and safety.

Conditions

Colon Cancer; MSS/pMMR; QL1706

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QL1706 + XELOX

Group Type: EXPERIMENTAL

QL1706

Intervention Type: DRUG

neoadjuvant administered at a dose of 5 mg/kg, intravenous infusion, every three weeks (Q3W), on day 1 of each cycle, 4 cycles

XELOX

Intervention Type: DRUG

Oxaliplatin 130 mg/m² by intravenous infusion on Day 1; Capecitabine 850-1000 mg/m² orally twice daily (morning and evening) from Day 1 to Day 14; 4 Cycles in total.

Interventions

QL1706

neoadjuvant administered at a dose of 5 mg/kg, intravenous infusion, every three weeks (Q3W), on day 1 of each cycle, 4 cycles

Intervention Type: DRUG

XELOX

Oxaliplatin 130 mg/m² by intravenous infusion on Day 1; Capecitabine 850-1000 mg/m² orally twice daily (morning and evening) from Day 1 to Day 14; 4 Cycles in total.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 75 years.
• Histologically or clinically confirmed initially resectable Stage III colon cancer according to the AJCC 8th edition.
• ECOG performance status of 0 or 1.
• pMMR/MSS status confirmed by a local testing center.
• No planned neoadjuvant radiotherapy.
• Participants must voluntarily participate in the study, sign an informed consent form, and demonstrate good compliance.
• Adequate organ function.

Exclusion Criteria

• Stage IV colon cancer.
• Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1.
• Current participation in another clinical trial and receiving investigational drugs.
• History of or contraindication to severe allergic reactions to immunotherapy.
• Pregnancy or lactation.
• Active infection requiring treatment.
• Use of immunosuppressive medications.
• Active cardiovascular disease, including stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure, or severe uncontrolled arrhythmia requiring medication that may preclude surgery.
• Patients with acute conditions such as obstruction, hemorrhage, or perforation that require immediate surgery.
• Any other condition deemed by the investigator to render the participant unsuitable for the clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Jing Hao

Deputy Director, Department of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Hao, Deputy Director, Department of Oncology, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Qilu hospital of Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Jian Wang, Dr.

Role: CONTACT

wang.jian@sdu.edu.cn

+86 18560088226

Facility Contacts

Jian Wang, Dr.

Role: primary

wang.jian@sdu.edu.cn

+86 18560088226

Other Identifiers

KYLL-202502-005-1

Identifier Type: -

Identifier Source: org_study_id