Treatment for advanced colorectal cancer using QL1706 alone or with other medications
An Open-label, Multicenter Phase II Study of QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC
This study is testing if the drug QL1706, alone or with other medications, can help people with advanced colorectal cancer feel better and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05799820 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter phase II study aims to evaluate the efficacy and safety of QL1706, either as a monotherapy or in combination with bevacizumab and XELOX, for patients with unresectable advanced or metastatic colorectal carcinoma. Participants will receive treatment and be monitored for response and safety outcomes. The study focuses on patients who have measurable disease and meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
Not a fit: Patients with additional malignancies, significant cardiovascular disease, or active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced colorectal cancer.
How similar studies have performed: Other studies have shown promise in using combination therapies for colorectal cancer, but the specific approach of QL1706 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Subjects participate voluntarily and sign informed consent. * 2. Age ≥ 18 and ≤ 80 years old, male or female. * 3. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum. * 4. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1). Exclusion Criteria: * 1. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers. * 2. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled). * 3. Has active autoimmune disease that has required systemic treatment in past 2 years. * 4. Significant cardiovascular disease.
Where this trial is running
Shanghai, Shanghai
- Shanghai East Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jin Li, MD — Shanghai East Hospital
- Study coordinator: Jin Li, MD
- Email: lijin@csco.org.cn
- Phone: +86 021-38804518
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.