QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of QL1203 and Placebo Respectively Combined With Chemotherapy in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233151
• Other study ID #: QL1203-003
• Status: Recruiting
• Phase: Phase 3
• Start date: January 20, 2020
• Est. completion date: July 30, 2025

Study information

• Verified date: May 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Xiaoyan Kang, CMO
• Phone: 0531-83129659
• Email: Xiaoyan.Kang[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 590
• Est. completion date: July 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed as metastatic colorectal adenocarcinoma and is not suitable for local treatment such as radical resection, radiotherapy, radiofrequency and so on.

• Man or woman at least 18 years old.

• At least one measurable lesion can be evaluated according to Response Evaluation Criteria In Solid Tumors 1.1(RECIST1.1) criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status should be 0-1 before randomization.

• The level of organ function must meet the requirements before randomization.

• Prior to randomization, the damage caused by other treatments had recovered to < grade 2 (CTCAE version 4.03).

Exclusion Criteria:

• Prior systemic or local chemotherapy for colorectal cancer,except in the following cases: the interval between the last dose of neoadjuvant or adjuvant therapy and recurrence> 6 months?

• Prior epithelial growth factor receptor(EGFR)-targeted drugs for colorectal cancer.

• Presence of central nervous system (CNS) metastases before the informed consent was signed, except for those who had stabilized CNS metastases for more than 4 weeks and had no symptoms after treatment.

• History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment.

• History of interstitial lung disease.

• Existing intestinal obstruction before randomization, active inflammatory bowel disease.

• Patients with non-healing abdominal fistula and gastrointestinal perforation before randomization.

• There were severe active infections or uncontrollable infections that required systemic treatment and could not be enrolled at the decision of the investigator within 14 days before randomization.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• QL1203
6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
• Placebo
6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
• mFOLFOX6 regimen
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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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