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This is a two-arm, randomized phase II clinical study. It is planned to enroll 44 patients with primary left-sided, RAS and BRAF wild-type metastatic colorectal cancer. After signing the informed consent, eligible subjects will be screened to enter the clinical study and assigned to two treatment groups using simple randomization and allocation concealment methods.
The treatment plans for the two groups are as follows:
Group A: FOLFOXIRI (Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + Bevacizumab (5mg/kg, i.v, Q2W) Group B: FOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + Cetuximab (500mg/m², i.v, Q2W) Both groups A and B will repeat the treatment every 2 weeks, for a maximum of 9 cycles. Then, the attending physician will decide whether to conduct maintenance treatment (Capecitabine or 5FU/LV with or without Bevacizumab is recommended).
Both groups A and B will be combined with QL1706 (5mg/kg, i.v, Q3W) for a maximum of 52 weeks.
Medication will continue until the researcher judges that there is no longer clinical benefit (the researcher makes a comprehensive judgment based on RECIST v1.1 imaging evaluation and clinical status, etc.), intolerable toxicity occurs, the subject withdraws informed consent, or other criteria for terminating treatment in the protocol are met, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group:FOLFOXIRI + QL1706 + Bevacizumab | Experimental | FOLFOXIRI (irinotecan 165 mg/m², iv, d1; oxaliplatin 85 mg/m², iv, d1; (levo)leucovorin 400 mg/m², iv, d1; 5-FU total dose 2400 mg/m², iv infusion (continuous for 48 hours), d1) +QL1706 (5mg/kg, i.v, Q3W) + bevacizumab (5 mg/kg, i.v., every 2 weeks). |
|
| B group:FOLFOX + QL1706 + Cetuximab | Active Comparator | FOLFOX (oxaliplatin 85 mg/m², intravenous infusion (2 hours), day 1; (levo)leucovorin (200) 400 mg/m², intravenous infusion (2 hours), day 1; 5-FU 400 mg/m², intravenous injection, followed by 2400 mg/m², intravenous infusion (continuous for 46-48 hours), day 1) +QL1706 (5mg/kg, i.v, Q3W) + cetuximab (500 mg/m², intravenous infusion, every 2 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOXIRI + QL1706 + Bevacizumab | Drug | FOLFOXIRI(Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + QL1706 (5mg/kg, i.v., Q3W) + Bevacizumab (5mg/kg, i.v., Q2W) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The percentage of participants in the analysis dataset who achieve a best overall response of Complete Response (CR) or Partial Response (PR) from the start of treatment until disease progression or withdrawal from the study. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The time from the first assessment of Complete Response (CR) or Partial Response (PR) until the first assessment of Progressive Disease (PD) or death from any cause. | 52 weeks |
| Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| rongbo lin | Contact | 13705919382 | rongbo_lin@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | China |
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| FOLFOX+QL1706+Cetuximab | Drug | FOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + QL1706 (5mg/kg, i.v., Q3W) + Cetuximab (500mg/m², i.v., Q2W). |
|
The proportion of patients whose tumors have shrunk or remained stable for a certain period of time, including cases of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
| 18 weeks |
| Progression Free Survival | The time from the day of enrollment until the first occurrence of disease progression (PD) or death due to any cause. | 52 weeks |
| Overall Survival | It refers to the time from the date of enrollment to the date of death due to any cause. | 52 weeks |
| Incidence of Adverse Events | fatigue, nausea/vomiting, abdominal pain and diarrhea, stomatitis, hepatic dysfunction, myelosuppression, etc. | 30 days after the end of study |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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