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

NCT07156682 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-09-05

No results posted yet for this study

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

Interventions

DRUG

QL1706

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

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.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Jing Hao, Deputy Director, Department of Oncology, MD, PhD · Qilu Hospital of Shandong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156682 on ClinicalTrials.gov