A Phase II, Single-arm, Multicenter Clinical Study of Adebrelimab Combined With Chemotherapy and Apatinib as First-line Treatment for Unresectable Locally Advanced or Metastatic Pulmonary Neuroendocrine Tumors

Beijing Chest Hospital0 sites39 target enrollmentJanuary 1, 2025

ConditionsNeuroendocrine Tumors

InterventionsAdebrelimab + Apatinib

DrugsAdebrelimab + Apatinib

Overview

Phase: Phase 2
Intervention: Adebrelimab + Apatinib
Conditions: Neuroendocrine Tumors
Sponsor: Beijing Chest Hospital
Enrollment: 39
Primary Endpoint: 12-month PFS rate (Progression-Free Survival rate)
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is an investigator-initiated research project aimed at exploring the efficacy and safety of Adebrelimab combined with chemotherapy and Apatinib as first-line treatment for unresectable locally advanced or metastatic pulmonary neuroendocrine tumors.

This is an experimental study that has been reviewed and approved by the Ethics Committee of Beijing Chest Hospital. The study plans to enroll 39 treatment-naïve patients with unresectable locally advanced or metastatic pulmonary neuroendocrine carcinoma, who will receive first-line treatment with Adebrelimab combined with chemotherapy and Apatinib to evaluate its efficacy and safety.

Registry

clinicaltrials.gov

Start Date

January 1, 2025

End Date

June 1, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Chest Hospital

Responsible Party

Principal Investigator

Tongmei Zhang

Chief Physician, Associate Professor, MD

Beijing Chest Hospital

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years, no gender restriction;
•Pathologically confirmed unresectable locally advanced or metastatic pulmonary neuroendocrine tumors (including large cell neuroendocrine carcinoma, small cell lung cancer, and carcinoid tumors). For carcinoid tumors, patients must be atypical carcinoid cases deemed by the investigator to require systemic treatment due to tumor-related symptoms or continuous tumor growth.
•No prior systemic anti-tumor treatment;
•Expected survival of at least 3 months;
•ECOG performance status: 0-2;
•At least one evaluable lesion based on imaging, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), with at least one measurable tumor lesion (non-lymph node lesion with a maximum diameter ≥ 10 mm or lymph node lesion with a short diameter ≥ 15 mm at baseline);
•Patients with brain metastases must either be asymptomatic or have stable brain metastases to be eligible;
•Normal function of major organs;
•Women of childbearing potential must have used reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result. Both male and female patients of childbearing potential must agree to use adequate contraception during the study and for 6 months after treatment;
•Subjects must voluntarily participate in the study, sign informed consent, demonstrate good compliance, and agree to follow-up.

Exclusion Criteria

•Subjects with extensive leptomeningeal metastases or active brain metastases with significant symptoms;
•Spinal cord compression not definitively treated with surgery and/or radiotherapy, or previously diagnosed and treated spinal cord compression without clinical evidence of stabilization for at least 1 week prior to randomization;
•Uncontrolled or symptomatic hypercalcemia;
•Prior treatment with any T-cell co-stimulation or immune checkpoint inhibitors;
•Use of immunosuppressive drugs within 14 days prior to the first dose of Adebrelimab;
•Active tuberculosis (TB) within 48 weeks before screening or a history of active TB infection, regardless of prior treatment;
•Vaccination with live attenuated or preventive vaccines within 4 weeks before the first dose or planned vaccination during the study;
•History of allogeneic bone marrow transplantation or solid organ transplantation;
•Severe cardiovascular disease;
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;