Loading clinical trials...

NOT_YET_RECRUITINGPHASE2

A Trial of Recaticimab and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable BTC

Efficacy and Safety of Recaticimab (PCSK9 Inhibitor) and Adebrelimab Combined With Chemotherapy as First-line Treatment for Unresectable/ Advanced Biliary Tract Carcinoma: A Single-arm, Phase II Study

NCT07062328•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The study aims to evaluate the efficacy and safety of Recaticimab and Adebrelimab in Combination With chemotherapy in patients with metastatic biliary tract carcinoma (BTC).

Detailed Description

The investigators are conducting a clinical research study to evaluate the effectiveness and safety of a novel combination therapy for patients with advanced, unresectable biliary tract carcinoma

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Provided informed consent and sign the informed consent form;
•2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
•3\. Histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.;
•4\. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
•5\. No previous systematic treatment for advanced BTC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic arterial infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) must have been completed at least 4 weeks prior to baseline radiological scanning, and any toxicity (except alopecia) induced by local regional therapy must have resolved to ≤ Grade 1 in accordance with National Cancer Institute - Common Terminology Criteria for Adverse Event version 5.0 (NCI-CTCAE v5.0);
•6\. No prior treatment with immune-mediated therapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, with the exception of therapeutic anticancer vaccines and adjuvant immunotherapy administered after curative resection
•7\. Have at least one measurable lesion (in accordance with RECIST v1.1, major diameter ≥ 10 mm of the measurable lesion in spiral CT scan or short diameter of swollen lymph node ≥ 15 mm; the lesion with previous local therapy can be used as target lesion after the progression is confirmed in accordance with RECIST v1.1)
•8\. Child-Pugh class: Grade A
•9\. ECOG-PS score: 0-1;
•10\. With a life expectancy of ≥ 12 weeks;
+4 more criteria

Exclusion Criteria

•1\. Other active malignant tumor exceptBTCwithin 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled;
•2\. A previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases that significantly affect lipid levels; a history of low cholesterol, low lipidemia, or related family history, or a family history of allergy to PCSK inhibitors
•3\. Planning to or previously received organ or allogenic bone marrow transplantation;
•4\. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;
•5\. Moderate or severe ascites with clinical symptoms that require therapeutic puncture and drainage, or Child-Pugh score \>2 (excluding those with only a small amount of ascites on imaging without accompanying clinical symptoms); uncontrolled or moderate to large pleural effusion, pericardial effusion;
•6\. History of gastrointestinal bleeding within 6 months prior to the start of study treatment or clear tendency of gastrointestinal bleeding;For example, those with a risk of bleeding or severe esophageal and gastric varices, active local gastrointestinal ulcer lesions, persistent positive fecal occult blood test cannot be enrolled (if the fecal occult blood test is positive at baseline, it can be rechecked. If it remains positive after re-examination, an endoscopy (EGD) should be performed. Those who are found to have esophageal and gastric varices with a high risk of bleeding by EGD cannot be enrolled);
•7\. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
•8\. Known genetic or acquired hemorrhage (e.g., coagulation dysfunction) or thrombotic tendency, for example, subject with hemophilia; current or recent (within 10 days prior to the start of study treatment) use of full-dose of oral or intravenous anticoagulant or thrombolytic drug for the purpose of treatment (preventive use of low-dose aspirin or low molecular weight heparin is allowed);
•9\. Current or recent (within 10 days prior to the start of study treatment) use of aspirin (\> 325 mg/day, maximum dose for antiplatelet) or dipyridamole, ticlopidine, clopidogrel and cilostazol;
•10\. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment, for example, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism;
+14 more criteria

Key Dates

Start Date

July 10, 2025

Primary Completion Date

December 10, 2026

Completion Date

April 20, 2028

Last Updated

July 14, 2025

Enrollment

ESTIMATED participants

Conditions

Biliary Tract Carcinoma

Interventions

Recaticimab and Adebrelimab

DRUG

GP chemotherapy

DRUG

Contacts

Dongsheng Zhang

CONTACT

020-87343795 zhangdsh@sysucc.org.cn

Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)

NCT06048133

Biliary Tract CarcinomaCholangiocarcinoma+1 more

View study

RECRUITINGPHASE2

GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma

NCT05668884

Biliary Tract Carcinoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Trial of Recaticimab and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable BTC

Inclusion Criteria

Exclusion Criteria

Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)

GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma

Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)

Durvalumab + Tremelimumab ± Paclitaxel in Advanced BTC After Platinum Chemotherapy.

Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer