Treatment of advanced biliary tract tumors with HRS-4642 alone or with adebrelimab
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.
This study is testing if a new treatment called HRS-4642, alone or with another drug called adebrelimab, can help people with advanced biliary tract cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | adebrelimab, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06620848 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of HRS-4642, both as a standalone treatment and in combination with adebrelimab, for patients suffering from advanced biliary tract cancer. Participants must have a confirmed diagnosis of unresectable or metastatic biliary tract tumors and have experienced progression or intolerance to prior systemic therapies. The study aims to determine the effectiveness of these treatments in managing the disease and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced biliary tract cancer that is unresectable or metastatic and who have previously received systemic therapy.
Not a fit: Patients with a known hypersensitivity to HRS-4642 or adebrelimab or those who have received anti-tumor chemotherapy within 4 weeks prior to the study may not benefit.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced biliary tract cancer who have limited treatment alternatives.
How similar studies have performed: While there have been studies on similar treatments for biliary tract cancer, the specific combination of HRS-4642 and adebrelimab is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-75 years old, male or female. 2. Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer. 3. Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy). 4. Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 5. ECOG performance status of 0-1. 6. With a life expectancy of ≥3 months. 7. Have adequate laboratory parameters and organ functions during the screening period. Exclusion Criteria: 1. Known history of hypersensitivity to any components of HRS-4642 or adebrelimab. 2. Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication. 3. Patients with untreated or active central nervous system tumor metastasis. 4. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jia Fan, M.D — Shanghai Zhongshan Hospital
- Study coordinator: Guoming Shi, M.D
- Email: shi.guoming@zs-hospital.sh.cn
- Phone: 13916969578
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.