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Efficacy and Safety of Sintilimab Combined with Nab-PP Plus Rh-endostatin in Locally Advanced/advanced and Recurrent Metastatic Squamous Non-small Cell Lung Cancer: a Single-arm, Multicenter Clinical Study

NCT06747169 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-12-27

No results posted yet for this study

Summary

The goal of this single-arm, multi-center phase II clinical study is to evaluate the efficacy and safety of recombinant human endostatin (rh-Endostatin) combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors in patients with locally advanced, advanced, or recurrent metastatic squamous non-small cell lung cancer (NSCLC).

The main questions it aims to answer are:

What is the progression-free survival (PFS) and objective response rate (ORR) of this combination therapy? What is the safety profile, including adverse event (AE) and serious adverse event (SAE) rates? Researchers will compare the treatment effects over time by evaluating tumor responses using RECIST 1.1 criteria and assessing quality of life using the EORTC QLQ-C30 (v3.0) and QLQ-CX24 scales.

Participants will:

Receive 4-6 cycles of rh-Endostatin combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors.

Continue maintenance treatment with rh-Endostatin and PD-1 inhibitors until disease progression or intolerable toxicity.

Conditions

  • Squamous Non-Small Cell Lung Cancer SqNSCLC

Interventions

DRUG

Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin

All patients were treated with a combination therapy consisting of sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin. The study is designed to assess the efficacy and safety of this treatment regimen in the specified population.

Sponsors & Collaborators

  • Jian-Guo Zhou, MD, PhD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2026-12-17
Completion
2026-12-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06747169 on ClinicalTrials.gov