Predicting how biliary tract tumors respond to immunotherapy
Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors
Zhejiang Cancer Hospital · NCT06048289
This study is testing if certain markers in tumor and blood samples can help predict how well immunotherapy will work for people with advanced biliary tract tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06048289 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify biomarkers that can predict the effectiveness of immunotherapy in patients with unresectable advanced or metastatic biliary tract tumors. Participants will receive PD-1/PD-L1 inhibitors combined with chemotherapy as their first-line treatment. The study will involve collecting tumor tissues through biopsies and analyzing them using genomic and transcriptomic techniques, along with blood and fecal samples to assess various biomarkers. The goal is to explore and identify predictive biomarkers that could guide future immunotherapy treatments for these tumors.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unresectable advanced or metastatic biliary tract tumors confirmed as adenocarcinoma.
Not a fit: Patients with other active malignant tumors or those unable to provide necessary biological samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with biliary tract tumors.
How similar studies have performed: While there have been studies exploring biomarkers in other cancers, this specific approach in biliary tract tumors is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over 18 years old; 2. Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma); 3. Confirmed as adenocarcinoma by histology; 4. Has not received systemic therapy in the past (patients who have not progressed within six months after the completion of neoadjuvant therapy or adjuvant therapy can be enrolled); 5. At least one measurable lesion according to RECIST 1.1 standard; 6. Plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment; 7. Sign informed consent, has good compliance and can cooperate with follow-up. Exclusion Criteria: 1. Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Biospecimen Retention Ying, Dr — Zhejiang Cancer Hospital
- Study coordinator: Jieer Ying, Dr
- Email: jieerying@aliyun.com
- Phone: 13858195803
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.
Conditions: Biliary Tract Tumor, Cholangiocarcinoma