LBL-024 combination treatment for advanced esophageal squamous cell carcinoma (Phase II, Substudy 03)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase II study testing LBL-024 given with chemotherapy agents (cisplatin, paclitaxel, 5‑fluorouracil) and the PD‑1 inhibitor tislelizumab in patients with advanced ESCC. The study begins with a small safety run‑in where a few subjects receive the combination and are observed for 21 days to confirm tolerability. If the combination is judged safe, the trial expands into a randomized, open, positive‑control phase with subjects assigned 2:1 to experimental versus control groups, enrolling up to 110 people. Key outcomes include tumor response per RECIST 1.1 and safety/tolerability measures, with regular clinical and laboratory monitoring across participating centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Age ≥ 18 years at the time of signing the informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
6. There is adequate organ and bone marrow function,Conforms to laboratory test results.
7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Exclusion Criteria:

1. 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.
2. Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
3. Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
4. Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
5. The patient has a Medical history of immunodeficiency, including HIV antibody positive.
6. Active hepatitis B or active hepatitis C.
7. Women during pregnancy or lactation.
8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Henan University of Science & Technology
  Luoyang, Henan, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Shandong Cancer Hospital
  Jinan, Shandong, China Recruiting
• Suining Central Hospital
  Suining, Sichuan, China Recruiting

Study contacts

• Principal investigator: Lin Shen — Peking University Cancer Hospital & Institute
• Study coordinator: Lin Shen
• Email: doctorshenlin@sina.cn
• Phone: 010-88121122

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing different doses of BI 3968621 alone or with ezabenlimab in adults with advanced cancer

  This study tests whether BI 3968621, alone or with ezabenlimab, can be given safely at different doses to adults with advanced solid tumors and whether it can slow or shrink tumors.

  Recruiting at 3 sites Phase 1 Boehringer Ingelheim · Sarasota, Florida and 9 other locations · NCT07851103

• LBL-024 combined with chemotherapy and immunotherapy for advanced gastric or gastroesophageal junction adenocarcinoma

  This study will test whether adding LBL-024 to capecitabine, oxaliplatin, and tislelizumab helps adults with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

  Recruiting Phase 2 Nanjing Leads Biolabs Co.,Ltd · Beijing, Beijing Municipality and 6 other locations · NCT07390383

• LBL-024 combined treatment for advanced biliary tract cancer and hepatocellular carcinoma.

  This study tests whether LBL-024 given with chemotherapy and bevacizumab helps adults with advanced biliary tract cancer or hepatocellular carcinoma.

  Recruiting at 8 sites Phase 2 Nanjing Leads Biolabs Co.,Ltd · Hefei, Anhui and 15 other locations · NCT07111546

• LBL-024 combination therapy for advanced non-small cell lung cancer (NSCLC)

  This study tests whether adding LBL-024 to chemotherapy or other cancer drugs helps people with advanced NSCLC respond better or live longer.

  Recruiting at 24 sites Phase 2 Nanjing Leads Biolabs Co.,Ltd · Hefei, Anhui and 23 other locations · NCT06783647

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.