QL1203 combined with chemotherapy for metastatic colorectal cancer
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
This study is testing if adding a new treatment called QL1203 to standard chemotherapy can help people with metastatic colorectal cancer feel better compared to those who only receive chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT04233151 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated wild-type RAS metastatic colorectal cancer who are not suitable for local treatment.
Not a fit: Patients who have previously received systemic or local chemotherapy for colorectal cancer or those with central nervous system metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic colorectal cancer.
How similar studies have performed: Other studies have shown promise with similar combination therapies, but the specific use of QL1203 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.