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

NCT05410197 | Unknown Phase 2 DMC

• 1 other identifier: BTC2022
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Biliary Tract Cancer

Keywords

Advanced Biliary Tract Cancer; First-Line Treatment

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

  Up to 2 years

Secondary Outcomes (4)

• Overall Survival (OS)

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Incidence of Adverse Events (AE)

  Up to 2 years

Study Arms (1)

Envofolimab + Lenvatinib + Gemcitabine + Cisplatin

EXPERIMENTAL

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

Drug: Envofolimab; Drug: Lenvatinib; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Envofolimab DRUG

400mg by subcutaneous injection every 3 weeks

Envofolimab + Lenvatinib + Gemcitabine + Cisplatin

Lenvatinib DRUG

8 mg orally once a day

Envofolimab + Lenvatinib + Gemcitabine + Cisplatin

Gemcitabine DRUG

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

Envofolimab + Lenvatinib + Gemcitabine + Cisplatin

Cisplatin DRUG

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

Envofolimab + Lenvatinib + Gemcitabine + Cisplatin

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained from the patient prior to treatment.
• Age \> 18 years at the time of study entry.
• Pathologically confirmed advanced biliary tract cancer, not having received systemic therapy.
• Measurable or evaluable lesions according to RECIST v1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Life expectancy ≥ 12 weeks.
• 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).
• Normal coagulation function (INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN, PT ≤ 1.5 × ULN), without active bleeding or thrombotic diseases.
• Willingness and ability to comply with the protocol.

You may not qualify if:

• Diagnosis of any second malignancy, except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix uteri.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• Previous treatment with Chinese herbal medicine or immunomodulators within 2 weeks, or radiotherapy treatment within 4 weeks prior to the first dose of administration.
• Abnormal thyroid function.
• Uncontrolled hypertension.
• 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.
• Active or prior documented autoimmune or inflammatory disorders.
• Any immunosuppressants or systemic steroid therapy (\> 10 mg daily dose of prednisone or equivalent) within 2 weeks prior to enrollment.
• Central nervous system metastases.
• Active infection or unknown fever(\>38.5℃) prior to the first dose of administration, except for cancerous fever.
• History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-associated pneumonia or severely impaired lung function.
• 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).
• Live vaccine administration within 4 weeks prior to the first dose of administration or probably during the study.
• History of psychotropic substance abuse, alcohol abuse, or drug use.
• Pregnancy or lactation

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

lenvatinib; 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

• Ming Kuang, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Ming Kuang, PhD

CONTACT

008687755766; kuangm@mail.sysu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: June 4, 2022
• First Posted: June 8, 2022
• Study Start: October 10, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)