QL1203 combined with chemotherapy for metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of QL1203 when used alongside the mFOLFOX6 chemotherapy regimen compared to a placebo with the same chemotherapy in patients with metastatic colorectal cancer. It is a randomized, double-blind, placebo-controlled, multi-center Phase III trial aiming to enroll 590 patients who have not received prior treatment for their condition. Participants will be assigned to either the QL1203 group or the placebo group in a 2:1 ratio, allowing for a robust comparison of treatment effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai, China Recruiting

Study contacts

• Principal investigator: Lin Shen, Professor — Peking University Cancer Hospital & Institute
• Study coordinator: Xiaoyan Kang, CMO
• Email: Xiaoyan.Kang@qilu-pharma.com
• Phone: 0531-83129659

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.