BridgeMD
New treatment option for Biliary Tract Cancer (BTC)
Official title Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct Tumors
ClinicalTrials.gov ID: NCT07726446
What this study is testing
What is PD-1 and chemotherapy?
PD-1 and chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary tract cancer (btc).
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 prospective, multicenter, single-arm, open-label Phase II clinical trial, planned to enroll 30 patients with unresectable locally advanced or metastatic iCCA/GBC. Patients will first receive cryoablation treatment, and two weeks after ablation, they will receive 8 cycles of immunotherapy combined with chemotherapy (Relatlimab α plus GC chemotherapy, every 3 weeks).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years, any gender;
- Histologically confirmed unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma or gallbladder cancer;
- No prior anti-tumor treatment;
- At least one measurable target lesion according to RECIST 1.1 tumor evaluation criteria, and at least one lesion suitable for ablation;
- No active autoimmune disease;
You likely can't join if
- Previously received systemic anti-tumor treatment;
- Active brain metastases; patients with asymptomatic brain metastases can be enrolled; for patients clinically suspected of central nervous system...
- Had other malignant tumors within 5 years before administration (except tumors cured with radical treatment, such as basal cell carcinoma of the...
- Allergic to the study drug (Rilafup Alpha Injection, or other immune checkpoint inhibitors);
- History of unstable angina; newly diagnosed angina within 3 months before screening or myocardial infarction within 6 months before screening...
- Urinalysis showing protein ≥ and confirmed 24-hour urine protein quantification \> 1.0g;
See the full eligibility criteria
- Age ≥18 years, any gender;
- Histologically confirmed unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma or gallbladder cancer;
- No prior anti-tumor treatment;
- At least one measurable target lesion according to RECIST 1.1 tumor evaluation criteria, and at least one lesion suitable for ablation;
- No active autoimmune disease;
- No concurrent malignancies;
- ECOG performance status 0-1;
- Expected survival ≥ 3 months;
- Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks before first dose), defined as:
- Blood count: neutrophils (NEUT) ≥ 1.2×10\^9/L; platelets (PLT) ≥ 90×10\^9/L; hemoglobin ≥ 90 g/dL;
- Liver function: AST and ALT ≤ 2.5× upper limit of normal (ULN); ALP ≤ 2.5×ULN; total bilirubin (TBIL) ≤ 1.5×ULN; if liver metastases, ALT and AST ≤ 5×ULN;
- INR ≤ 1.25;
- Serum creatinine ≤ 1.5× ULN or creatinine clearance (CrCl) ≥ 30 mL/min (using Cockcroft-Gault formula);
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective medical contraception from signing the informed consent until 6 months after the...
- Participants voluntarily join the study, sign the informed consent form, and can comply with scheduled visits and related procedures.
- Previously received systemic anti-tumor treatment;
- Active brain metastases; patients with asymptomatic brain metastases can be enrolled; for patients clinically suspected of central nervous system metastasis, a CT or MRI must be performed within 28 days before...
- Had other malignant tumors within 5 years before administration (except tumors cured with radical treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ...
- Allergic to the study drug (Rilafup Alpha Injection, or other immune checkpoint inhibitors);
- History of unstable angina; newly diagnosed angina within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmias (including QTcF: men ≥ 450 ms, women ≥ 470 ms) requiring...
- Urinalysis showing protein ≥ and confirmed 24-hour urine protein quantification \> 1.0g;
- Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, or other conditions requiring corticosteroid therapy; history of chronic autoimmune diseases, such as systemic lupus erythematosus; history of...
- Currently participating in treatment clinical research treatment, or have received other study drugs or devices within 4 weeks before first administration;
- History of substance abuse that cannot be stopped or mental disorders; Any other situation in which the investigator believes the patient is not suitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.