Adebrelimab Combined with Apatinib and Gemcitabine and Cisplatin (GP) First-line Treatment for Unresectable Biliary Tract Carcinoma

NCT06749730 | Recruiting Phase 2

• 1 other identifier: BTC-II-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine/cisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China.

Conditions

Unresectable Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.

  From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 6 months after the last subject enrolled

Secondary Outcomes (4)

• Overall Survival(OS)

  From first dose of study intervention until death, at least 12 months after the last subject enrolled

• Objective Response Rate (ORR)

  From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 3 months after the last subject enrolled

• Duration of Response(DOR)

  From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 6 months after the last subject enrolled

• Incidence of treatment-emergent adverse events(AEs)

  From first dose of study intervention until 90 days after last dose or death (whichever occurs first)

Study Arms (1)

adebrelimab combined with apatinib and gemcitabine and cisplatin

EXPERIMENTAL

Drug: Adebrelimab; Drug: Apatinib; Drug: gemcitabine and cisplatin

Interventions

Adebrelimab DRUG

adepelizumab ,1200mg, q3w

adebrelimab combined with apatinib and gemcitabine and cisplatin

Apatinib DRUG

apatinib，250mg，QD

adebrelimab combined with apatinib and gemcitabine and cisplatin

gemcitabine and cisplatin DRUG

cisplatin 25mg/m2，gemcitabine 1000mg/m2 d1,d8，q3w

adebrelimab combined with apatinib and gemcitabine and cisplatin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18 to 80 years old, regardless of gender;
• Histologically confirmed, unresectable advanced or metastatic BTC including cholangiocarcinoma (intrahepatic or extrahepatic), gallbladder carcinoma.
• \. Patients who have not received systematic treatment for BTC in the past .
• At least one measurable lesion (according to RECIST v1.1 requirements).
• ECOG PS: 0-1 points;
• Expected survival time ≥ 12 weeks;
• \. The main organs are functioning normally and meet the following requirements White blood cell count ≥ 3.0× 10 9/L; Hb ≥ 90 g/l; Absolute neutrophil count ≥ 1.5× 10 9/L; Platelet count ≥ 100× 10 9/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤ 2.5 times the upper limit of normal limit (ULN); Total bilirubin ≤ 2 times of ≤ULN; Serum creatinine ≤ 1.5 times of ≤ULN; Albumin ≥ 30 g/l;
• \. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days prior to enrollment, and voluntarily use appropriate methods of contraception during observation and within 8 weeks after the last administration of study medication; For males, surgical sterilization should be performed, or appropriate methods of contraception should be agreed upon during observation and within 8 weeks after the last administration of study medication;
• \. The subjects voluntarily joined this study, signed an informed consent form, and cooperated with follow-up.

You may not qualify if:

• \. Histologically diagnosed as neuroendocrine carcinoma;
• \. People who are allergic to adebelizumab, apatinib, gemcitabine, cisplatin or their auxiliary materials;
• \. Systemic treatment in the past;
• \. Pleural effusion, pericardial effusion or ascites accompanied by clinical symptoms and judged by the researcher to require frequent drainage;
• \. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
• \. Active or uncontrollable serious infection (≥ CTCAE grade 5.02 infection), including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia, and unexplained fever \> 38.5℃ before the first administration;
• \. Liver cirrhosis and active hepatitis; Hepatitis B reference: HBsAg positive, and HBV DNA exceeds the upper limit of normal value (1000 copies /ml or 500 IU/ml); Patients with hepatitis B virus (HBV) infection or cured HBV infection in the past (defined as the existence of hepatitis B core antibody \[HBcAb\] and the absence of HBsAg, and those with normal HBV DNA value during the screening period can be included; Hepatitis C reference: HCV antibody is positive, and the detection value of HCV virus titer exceeds the upper limit of normal value /HCV RNA or HCV Ab detection indicates acute and chronic infection;
• \. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
• Within 5 years, the subject has other malignant tumors in the past or at the same time and needs active treatment (except for fully treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and breast cancer in situ, if the estimated 5-year survival rate is more than 90%);
• \. There is an uncorrectable coagulation disorder;
• \. Severe liver diseases (such as liver cirrhosis), kidney diseases, respiratory diseases, uncontrollable diabetes or other types of systemic diseases.
• \. Patients whose imaging shows that the tumor has invaded important blood vessels or who are judged by the researchers to be very likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
• \. Active autoimmune disease or immunodeficiency, or the following medical history, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.) shall not be included. The following exceptions are made: patients with a history of autoimmune hypothyroidism but receiving thyroid hormone replacement therapy can be included in the study. Patients with type 1 diabetes whose blood sugar has been controlled after insulin administration can participate in this study.
• , Within 14 days prior to signing the informed consent form, use immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dose\>10mg/day prednisone or other therapeutic hormones)
• Arterial/venous thrombosis events occurred within 6 months before the first administration, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral embolism, etc.), deep venous thrombosis and pulmonary embolism;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

HeNan

Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

apatinib; Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Ying Liu, MD

  Study Principal Investigator Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Liu, MD

CONTACT

+86 137 8360 4602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: December 27, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-07

Locations

CN (1)