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

NCT07156682 | Not Yet Recruiting Phase 2

• 1 other identifier: KYLL-202502-005-1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

Iparomlimab and Tuvonralimab; QL1706; Neoadjuvant; MSS/pMMR; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  No residual viable tumor cells were found in the postoperative pathological assessment.

  Approximately 1 month after surgery.

Secondary Outcomes (6)

• Major Pathological Response (MPR)

  Approximately 1 month after surgery.

• Pathological Response (PR)

  Approximately 1 month after surgery.

• Clinical Complete Response (cCR)

  Approximately 4 months after last participant enrollment.

• Event-Free Survival (EFS)

  Approximately 2 years after last participant enrollment.

• Overall Survival (OS)

  Approximately 2 years after last participant enrollment.

Study Arms (1)

QL1706 + XELOX

EXPERIMENTAL

Drug: QL1706; Drug: XELOX

Interventions

QL1706 DRUG

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

QL1706 + XELOX

XELOX 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.

QL1706 + XELOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

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

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Wang, Dr.

CONTACT

+86 18560088226; wang.jian@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Department of Oncology

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

CN (1)