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Compares treatment options for Advanced Biliary Tract Cancer
Official title A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC)
ClinicalTrials.gov ID: NCT07229625
What this study is testing
What is SHR-8068 Injection?
SHR-8068 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized, open-label, multicenter phase III clinical trial, aiming to evaluate the efficacy and safety of SHR-8068 combined with adbelimab and platinum-based chemotherapy in contrast to varicumab combined with platinum-based chemotherapy in the first-line treatment of patients with advanced BTC.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
- No previous systemic anti-tumor treatment has been received;
- At least one measurable lesion that complies with the RECIST v1.1 standard;
- ECOG PS score: 0-1 point;
- The expected survival period is ≥ 3 months;
You likely can't join if
- Other pathological types of cholangiocarcinoma other than adenocarcinoma;
- Malignant tumor of the ampulla;
- Have had or concurrently suffered from other malignant tumors;
- Those with concurrent biliary obstruction and at risk of biliary tract infection;
- Those with any active or known autoimmune diseases.
See the full eligibility criteria
- Locally advanced or recurrent/metastatic biliary adenocarcinoma that is inoperable and confirmed by histology or cytology;
- No previous systemic anti-tumor treatment has been received;
- At least one measurable lesion that complies with the RECIST v1.1 standard;
- ECOG PS score: 0-1 point;
- The expected survival period is ≥ 3 months;
- Good organ function level;
- Negative blood pregnancy (for women of childbearing age) and not in the lactation period, adhering to efficient contraceptive requirements;
- Patients voluntarily joined this study and signed informed consent.
- Other pathological types of cholangiocarcinoma other than adenocarcinoma;
- Malignant tumor of the ampulla;
- Have had or concurrently suffered from other malignant tumors;
- Those with concurrent biliary obstruction and at risk of biliary tract infection;
- Those with any active or known autoimmune diseases.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.