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The purpose of this study is to determine the treatment effect of QL1203 in combination with mFOLFOX6 compared to Placebo in combination with mFOLFOX6 as first line therapy for metastatic colorectal cancer.
The study is a randomized, double-blind, Placebo-controlled, multi-center Phase III study. It is planned to enroll 590 patients with previously untreated wild-type RAS metastatic colorectal cancer. Subjects are randomized into the QL1203 combined with Oxaliplatin/5-fluorouracil/ Leucovorin or Placebo combined with Oxaliplatin/5-fluorouracil/ Leucovorin treatment group by a ratio of 2:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mFOLFOX6 + QL1203 | Experimental | Participants receive QL1203, 6mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity |
|
| mFOLFOX6 + Placebo | Active Comparator | Participants received Placebo,6 mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1203 | Drug | 6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival(PFS) | Progression-free survival (PFS), assessed by blinded independent central review committee, is defined as the time from randomization to disease progression per RECIST v1.1 criteria or death. | From randomization until disease progression up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Kang, CMO | Contact | 0531-83129659 | Xiaoyan.Kang@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, Professor | Peking University Cancer Hospital & Institute | Principal Investigator |
| Weijian Guo, Professor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Placebo | Drug | 6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy. |
|
| mFOLFOX6 regimen | Drug | The mFOLFOX6 regimen is consist of oxaliplatin 85 mg/m^2 intravenous (IV) infusion on Day 1;leucovorin, 200 mg/m^2 on Days 1 and 5-fluorouracil 400 mg/m^2 IV bolus on day 1, then 1200 mg/m^2/dx2days(total 2400 mg/m^2 over 46-48 hours) IV continuous infusion. Each cycle was 14 days. |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |