A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Leads Biolabs Co.,Ltd

About this trial

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour.

Eligibility criteria

Qualifiers

Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.

Age ≥ 18 years at the time of signing the informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

The expected survival time is at least 12 weeks.

Disqualifiers

Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.

Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.

Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.

Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.

Trial design

Treatments tested in this trial

  • LBL-024 for Injection
  • Cisplatin Injection
  • Paclitaxel Injection
  • Tislelizumab Injection
  • 5-Fluorouracil injection
  • Capecitabine tablets

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanjing Leads Biolabs Co.,Ltd

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator