Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN)

NCT ID: NCT05410197

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2025-08-01

Brief Summary

This is a phase 2, single-arm, open label study. The purpose is to investigate both the efficacy and safety of Envofolimab and Lenvatinib in combination with Gemcitabine plus Cisplatin for treatment of advanced biliary tract cancer as first-line treatment.

Detailed Description

The trial will recruit 43 patients. At the first step, 10 patients will be recruited. Only when at least 4 patients achieve objective response will the trial enter the second step and continue to recruit other patients. After being enrolled, all patients giving written informed consent will receive treatment until progression of disease, unacceptable toxicity or death. The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

Conditions

Advanced Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Envofolimab + Lenvatinib + Gemcitabine + Cisplatin

Single-arm trial whereby all consented, enrolled, eligible patients receive Envofolimab, Lenvatinib, Gemcitabine and Cisplatin

Group Type: EXPERIMENTAL

Envofolimab

Intervention Type: DRUG

400mg by subcutaneous injection every 3 weeks

Lenvatinib

Intervention Type: DRUG

8 mg orally once a day

Gemcitabine

Intervention Type: DRUG

1000mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

Cisplatin

Intervention Type: DRUG

25mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

Interventions

Envofolimab

400mg by subcutaneous injection every 3 weeks

Intervention Type: DRUG

Lenvatinib

8 mg orally once a day

Intervention Type: DRUG

Gemcitabine

1000mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

Intervention Type: DRUG

Cisplatin

25mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Kuang, PhD

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Kuang, PhD

Role: CONTACT

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

Facility Contacts

Ming Kuang, Ph.D.

Role: primary

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

Other Identifiers

BTC2022

Identifier Type: -

Identifier Source: org_study_id