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NCT Number: NCT07156682

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms MSS/pMMR Neoplasms Neoplasms by Site QL1706

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

Location contact

Jian Wang, Dr.

CONTACT

[email protected]

+86 18560088226

Jing Hao, Deputy Director, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Pathological Complete Response (pCR)

    Time frame: Approximately 1 month after surgery.

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

Secondary outcomes

  1. Major Pathological Response (MPR)

    Time frame: Approximately 1 month after surgery.

    Postoperative pathology shows at least 10% tumor regression.

  2. Pathological Response (PR)

    Time frame: Approximately 1 month after surgery.

    Postoperative pathology shows at least 50% tumor regression.

  3. Clinical Complete Response (cCR)

    Time frame: Approximately 4 months after last participant enrollment.

    No evidence of residual tumor is found via imaging, endoscopic examination, and clinical assessment

  4. Event-Free Survival (EFS)

    Time frame: Approximately 2 years after last participant enrollment.

    The time from initial treatment to the occurrence of any event, including disease progression, treatment discontinuation for any reason, or death.

  5. Overall Survival (OS)

    Time frame: Approximately 2 years after last participant enrollment.

    The time from initial treatment to death from any cause

  6. Adverse Event (AE)

    Time frame: Approximately 2 month after surgery.

    Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Wang, Dr.

CONTACT

[email protected]

+86 18560088226

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

A Single-Arm, Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) Plus XELOX as Neoadjuvant Therapy in Patients With Microsatellite Stable (pMMR/MSS) Resectable Stage III Colon Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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