QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
QL1706
Drugneoadjuvant administered at a dose of 5 mg/kg, intravenous infusion, every three weeks (Q3W), on day 1 of each cycle, 4 cycles
XELOX
DrugOxaliplatin 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.
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: QL1706 + XELOXExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pathological Complete Response (pCR)
No residual viable tumor cells were found in the postoperative pathological assessment.
Time frame
Approximately 1 month after surgery.Secondary outcomes
1
Major Pathological Response (MPR)
Postoperative pathology shows at least 10% tumor regression.
Time frame
Approximately 1 month after surgery.2
Pathological Response (PR)
Postoperative pathology shows at least 50% tumor regression.
Time frame
Approximately 1 month after surgery.3
Clinical Complete Response (cCR)
No evidence of residual tumor is found via imaging, endoscopic examination, and clinical assessment
Time frame
Approximately 4 months after last participant enrollment.4
Event-Free Survival (EFS)
The time from initial treatment to the occurrence of any event, including disease progression, treatment discontinuation for any reason, or death.
Time frame
Approximately 2 years after last participant enrollment.Sponsors and contacts
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Source ClinicalTrials.gov
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