Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with unresectable biliary tract carcinoma, which is a type of cancer that affects the bile ducts and cannot be removed through surgery. The study combines three different treatment methods: a procedure called ERCP-RFA that helps reduce the tumor size and relieve bile duct blockages, followed by two medications—envafolimab, which helps the immune system target cancer cells, and surufatinib, which aims to stop tumors from growing and spreading. The goal is to see if this combined treatment can effectively slow down the progression of the cancer.

To be eligible for this trial, participants must be between 18 and 79 years old, have a confirmed diagnosis of biliary tract tumors, and not have received prior treatments for their cancer. They should also have at least one measurable tumor and be assessed by a doctor as having a good chance of survival for at least 12 weeks. This trial is not yet recruiting participants, but once it starts, those who join can expect to undergo the combined treatment and be closely monitored for their health and response to therapy throughout the study.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Sign written informed consent.;
• • 18-79 years of age (at the time of signing the informed consent);
• • Patients with confirmed diagnosis of biliary tract tumors by histopathologic examination;
• • Patients have received no previous local treatment or any systemic treatment, and have been considered unsuitable for radical therapies
• • Patients assessed by the investigator as unsuitable for or refusing chemotherapy
• • At least one measurable lesion (≥10 mm long diameter on CT scan for tumor lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria);
• • ECOG score: 0-1;
• • Expected survival ≥ 12 weeks;
• • Vital organ function in accordance with the following requirements (excluding any blood components and cell growth factors within 14 days): 1) blood routine: neutrophils ≥ 1.5 × 10\^9/L platelet count ≥ 60 × 10\^9/L hemoglobin ≥ 90 g/L; 2) liver and kidney function: serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤ 1.5 times ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 ULN (≤ 5ULN if liver function abnormalities are due to liver metastases); urine protein \< 2 +; if urine protein ≥ 2 +,24-hour urine protein must show protein ≤ 1g;
• • Normal coagulation, no active bleeding and thrombosis disease 1) international normalized ratio INR ≤ 1.5 × ULN; 2) partial thromboplastin time APTT ≤ 1.5 × ULN; 3) prothrombin time PT ≤ 1.5 × ULN;
• • Non-surgically sterilized or female patients of childbearing age who need to use a medically recognized contraceptive (such as an intrauterine device, contraceptive pills or condom) during study treatment and within 3 months after the end of study treatment; non-surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before study enrollment; and must be non-lactating; non-surgically sterilized or male patients of childbearing age who need to agree to use a medically recognized contraceptive during study treatment and within 3 months after the end of study treatment with their spouses.
• • Willing and able to be followed up until death or end of study or study termination.
• Exclusion Criteria:
• • History of other malignancies (except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix after radical surgery).
• • Previous treatment with other immune checkpoints; the subject known to have a prior allergy to macromolecular protein preparations;
• • Presence of any active autoimmune disease or history of autoimmune disease in the subject;
• • Subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose \>10mg/day prednisone or other equipotent hormone) and who continue to be on it within 2 weeks prior to enrollment.
• • Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
• • Patients with poorly controlled cardiac clinical symptoms or diseases such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
• • Subjects with active infection or unexplained fever \>38.5 degrees Celsius during screening and prior to the first dose (if the subject had fever due to the tumor, as determined by the investigator, he could be enrolled);
• • Previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.;
• • Subjects with congenital or acquired immune deficiency (e.g., HIV-infected individuals)
• • Subjects who have had a live bacterial vaccine or live attenuated vaccine vaccine within 4 weeks prior to the first dose of study treatment.
• • Subject has a known history of psychiatric drug abuse, alcoholism, or drug abuse;
• • Patients who cannot be administered orally
• • The subject had received treatment with traditional Chinese medicine within 2 weeks before the first treatment
• • ECOG score: ≥2
• • Patients with any other diseases, dysfunction caused by metastatic lesions, or suspected disease found by physical examination, indicating possible contraindications to the use of the investigational drug or putting the patients at high risk of treatment-related complications.