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Advanced Biliary Tract CancerPhase 2NCT05410197

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

A Phase 2 study testing Envofolimab, Lenvatinib and Gemcitabine in people with Advanced Biliary Tract Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Biliary Tract Cancer
What is being tested?
Envofolimab, Lenvatinib and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
10 Oct 2022to 1 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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
  • Exclusion from the study by the judgement of investigator, due to some factors that may lead to the forced termination of the study.

Trial locations and contacts

1 site in 1 country.

Ming Kuang, PhD contact

008687755766 ext. 8576

kuangm@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Ming Kuang, Ph.D., 008687755766 ext. 8576, kuangm@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Envofolimab, Lenvatinib, Gemcitabine, Cisplatin
Keywords
Advanced Biliary Tract Cancer, First-Line Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnvofolimabDrug

    400mg by subcutaneous injection every 3 weeks

  • LenvatinibDrug

    8 mg orally once a day

  • GemcitabineDrug

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

  • CisplatinDrug

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

Study groups in NCT05410197
Study groupRoleWhat they receive
Envofolimab + Lenvatinib + Gemcitabine + CisplatinExperimentalSingle-arm trial whereby all consented, enrolled, eligible patients receive Envofolimab, Lenvatinib, Gemcitabine and Cisplatin
Receives: Drug: Envofolimab; Drug: Lenvatinib; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Overall Survival (OS)

    OS is defined as the time from first treatment to death, regardless of disease recurrence.

    Measured: Up to 2 years

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from the first dose of administration to progression or death.

    Measured: Up to 2 years

  3. Disease control rate (DCR)

    DCR is defined as the percentage of patients who have achieved CR, PR or stable disease(SD), as measured by RECIST 1.1 criteria.

    Measured: Up to 2 years

  4. Incidence of Adverse Events (AE)

    The percentage of patients who suffer grade 3 or worse adverse events from the first dose of administration to last follow-up, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start10 Oct 2022
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05410197
Sponsor's protocol ID
BTC2022
Status last verified
Oct 2022
First submitted
4 Jun 2022
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envofolimab, Lenvatinib and Gemcitabine in people with Advanced Biliary Tract Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ming Kuang, PhD (008687755766 ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05410197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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