Combination treatment for advanced biliary tract cancer

Envofolimab and Lenvatinib in Combination With Gemcitabine Plus Cisplatin for Patients With Advanced Biliary Tract Cancer as First-Line Treatment: A Single-arm, Open-label, Phase II Study

This study is testing a new combination of treatments for people with advanced biliary tract cancer to see if it helps them respond better than current options.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: radiation, prednisone, Envofolimab, Lenvatinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05410197 on ClinicalTrials.gov

What this trial studies

This phase 2, single-arm, open-label trial aims to evaluate the efficacy and safety of Envofolimab and Lenvatinib combined with Gemcitabine and Cisplatin as a first-line treatment for patients with advanced biliary tract cancer. The study will initially recruit 10 patients, and if at least 4 show an objective response, it will expand to include a total of 43 participants. Patients will receive treatment until disease progression, unacceptable toxicity, or death, with regular evaluations of tumor response and long-term survival follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with pathologically confirmed advanced biliary tract cancer who have not received prior systemic therapy.

Not a fit: Patients with prior systemic therapy for biliary tract cancer or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective first-line therapy for patients with advanced biliary tract cancer.

How similar studies have performed: While there have been studies on individual components, this specific combination approach is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent obtained from the patient prior to treatment.
2. Age \> 18 years at the time of study entry.
3. Pathologically confirmed advanced biliary tract cancer, not having received systemic therapy.
4. Measurable or evaluable lesions according to RECIST v1.1 criteria.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
6. Life expectancy ≥ 12 weeks.
7. Adequate hematologic (absolute neutrophil count ≥ 1,500/μL, platelets count ≥ 100,000/μL, hemoglobin ≥ 9.0 g/dL), renal (serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault), urinary protein \< 2+ or ≤ 1g/24h) and hepatic function (total serum bilirubin ≤ 1.5 ×ULN, serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 2.5 × ULN).
8. Normal coagulation function (INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN, PT ≤ 1.5 × ULN), without active bleeding or thrombotic diseases.
9. Willingness and ability to comply with the protocol.

Exclusion Criteria:

1. Diagnosis of any second malignancy, except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix uteri.
2. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
3. Previous treatment with Chinese herbal medicine or immunomodulators within 2 weeks, or radiotherapy treatment within 4 weeks prior to the first dose of administration.
4. Abnormal thyroid function.
5. Uncontrolled hypertension.
6. Uncontrolled cardiac disease, including but not limited to heart failure (NYHA class II-IV), unstable angina pectoris, myocardial infarction within 1 year or cardiac arrhythmia.
7. Active or prior documented autoimmune or inflammatory disorders.
8. Any immunosuppressants or systemic steroid therapy (\> 10 mg daily dose of prednisone or equivalent) within 2 weeks prior to enrollment.
9. Central nervous system metastases.
10. Active infection or unknown fever(\>38.5℃) prior to the first dose of administration, except for cancerous fever.
11. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-associated pneumonia or severely impaired lung function.
12. Inherited or acquired immunodeficiency disease, including but not limited to infection of HIV or active hepatitis (HBV DNA ≥ 1000 IU/ml or HCV RNA ≥ 1000 IU/ml).
13. Live vaccine administration within 4 weeks prior to the first dose of administration or probably during the study.
14. History of psychotropic substance abuse, alcohol abuse, or drug use.
15. Pregnancy or lactation
16. Exclusion from the study by the judgement of investigator, due to some factors that may lead to the forced termination of the study.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Ming Kuang, PhD

Conditions Advanced Biliary Tract Cancer; First-Line Treatment