Clinical trial · Interventional
QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety
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
NCT04233151CI-TRIAL-00066746unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFOX6 regimen | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| QL1203 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mFOLFOX6 + QL1203
- description
- 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
- interventionNames
- Drug: QL1203
- Drug: mFOLFOX6 regimen
- type
- ACTIVE_COMPARATOR
- label
- mFOLFOX6 + Placebo
- description
- 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.
- interventionNames
- Drug: Placebo
- Drug: mFOLFOX6 regimen
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.