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

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Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate (ORR)

Secondary Outcome

 Over Survival (OS)

Condition

Advanced Biliary Tract Cancer

Intervention

Envofolimab

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

43

Start Date

July 1, 2022

Completion Date

August 1, 2025

Primary Completion Date

August 1, 2024

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ming Kuang, PhD, 008687755766, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05410197

Organization ID

BTC2022


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

Ming Kuang, PhD, Study Chair, First Affiliated Hospital, Sun Yat-Sen University


Verification Date

June 2022