Menu
Not yet recruiting NCT07156682

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

Phase II Interventional Colon Cancer MSS/pMMR QL1706

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QL1706, XELOX.
Who it may be relevant to
Registry conditions: Colon Cancer, MSS/pMMR, QL1706. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

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.

Primary outcome measures

  • Pathological Complete Response (pCR) [Time frame: Approximately 1 month after surgery.]
Secondary outcome measures (6)
  • Major Pathological Response (MPR) [Time frame: Approximately 1 month after surgery.]
  • Pathological Response (PR) [Time frame: Approximately 1 month after surgery.]
  • Clinical Complete Response (cCR) [Time frame: Approximately 4 months after last participant enrollment.]
  • Event-Free Survival (EFS) [Time frame: Approximately 2 years after last participant enrollment.]
  • Overall Survival (OS) [Time frame: Approximately 2 years after last participant enrollment.]
  • Adverse Event (AE) [Time frame: Approximately 2 month after surgery.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Qilu hospital of Shandong University — Jinan

Identifiers

NCT: NCT07156682 · KYLL-202502-005-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗