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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Recaticimab and Adebrelimab
  • GP chemotherapy

Treatment groups

39 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Sun Yat-Sen University Cancer Center

Sponsor institution

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborator