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.
Patients must voluntarily participate in the study and provide written informed consent.
Age between 18 and 70 years, applicable to both sexes.
Histologically or cytologically confirmed advanced or metastatic (Stage IIIB, IIIC, or IV) squamous NSCLC without driver gene mutations.
At least one measurable target lesion per RECIST 1.1 criteria, untreated with local therapies (e.g., radiotherapy).
History of severe hypersensitivity or allergic reactions to humanized antibodies or fusion proteins.
Known hypersensitivity to recombinant human endostatin or any component of antibody preparations.
Diagnosed with immunodeficiency or receiving systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment (physiologic doses of corticosteroids, such as ≤10 mg/day prednisone or equivalent, are allowed).
Active, known, or suspected autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism). However, patients with Type 1 diabetes, hypothyroidism requiring only hormone replacement, skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or autoimmune conditions not expected to recur in the absence of external triggers may be included.
Single group
Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin
DrugAll 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.
Progression-Free Survival (PFS)
PFS refers to the length of time from the start of treatment until the tumor progresses or the patient dies, typically assessed through imaging or clinical evaluation. This endpoint reflects the effectiveness of the treatment in delaying disease progression. PFS is particularly useful in evaluating the clinical efficacy of new drugs or therapies. An extension of PFS is usually considered a sign of effective treatment.
Overall survival（OS）
OS is defined as the time from the initiation of treatment to the date of death from any cause. If a patient is alive at the end of the study or lost to follow-up, OS will be censored at the last known date of follow-up.
Adverse Events (AE) and Serious Adverse Events (SAE)
Safety and tolerability will be assessed by recording the incidence of adverse events (AEs) and serious adverse events (SAEs). The proportion of patients experiencing AEs/SAEs and the proportion of events leading to treatment discontinuation will be recorded and analyzed.
Objective response rate(ORR)
ORR refers to the proportion of patients who achieve either a complete response (CR) or partial response (PR) during treatment. This endpoint reflects the effectiveness of the treatment in controlling the tumor. It is typically assessed through imaging techniques (e.g., CT, MRI) and scored based on RECIST (Response Evaluation Criteria in Solid Tumors) or similar criteria. ORR is a common efficacy endpoint in cancer clinical trials.
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Jian-Guo Zhou, MD, PhD
Lead sponsor
Second Affiliated Hospital of Zunyi Medical University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
