Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy

NCT06279754 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ZLXGBXKYXM-031-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.

Conditions

Locally Advanced Squamous Non-small Cell Lung Cancer

Keywords

recombinant human endostatin; envafolimab; synchronal radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• objective response rate

  After treatment, the ratio of patients assessed as CR and PR according to RECIST 1.1

  After 6 weeks

Secondary Outcomes (2)

• Overall survival

  The time from the start of treatment to death or last follow-up

• Progression-free survival

  The time from the start of treatment to the first recording of disease progression

Study Arms (1)

recombinant human endostatin Group

EXPERIMENTAL

Recombinant human endostatin and enrolizumab injection combined with Synchronal Radiochemotherapy

Drug: Recombinant Human Endostatin Injection

Interventions

Recombinant Human Endostatin Injection DRUG

Recombinant Human Endostatin Injection：210 mg, intravenous infusion for 72 hours, once every three weeks cycle Evafolimab Injection：Subcutaneous injection on day 1, 8, and 15, once every three weeks cycle

Also known as: Evafolimab Injection

recombinant human endostatin Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient voluntarily participated in this study, voluntarily underwent treatment and follow-up, and signed an informed consent form;
• According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification, 8th edition of the TNM staging classification for lung cancer, locally advanced and unresectable stage III non-small cell lung cancer with histopathological diagnosis;
• According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), there should be at least one imaging measurable lesion; Patients who have not received PD-1/PD-L1 antibody treatment in the past.
• years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;
• Main organ functions meet treatment standards
• Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; Men should agree to patients who must use contraceptive measures during the study period and within 6 months after the end of the study period.

You may not qualify if:

• Patients who have previously received PD-1/PD-L1 antibody treatment;
• Respiratory syndrome caused by pleural effusion or ascites (according to NCICTCAE classification ≥ grade 2 dyspnea;
• Patients with brain metastases accompanied by symptoms or symptom control time less than 2 months;
• Has experienced or currently suffers from other malignant tumors within 5 years;
• Within the first 4 weeks of grouping or during the medication period of this study, it is planned to undergo systemic anti-tumor therapy, including cytotoxic therapy and targeted drug therapy. Received radiotherapy within 4 weeks prior to grouping;
• Patients with any severe and/or uncontrolled diseases
• Received significant surgical treatment, open biopsy, or obvious traumatic injury within 28 days prior to grouping;
• Patients with any signs of bleeding or medical history, regardless of severity; Within the first 4 weeks of grouping, patients with any bleeding or bleeding events ≥ CTCAE level 3, with unhealed wounds, ulcers, or fractures;
• Individuals who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;
• Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
• Participated in clinical trials of other anti-tumor drugs within four weeks;
• According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study;

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

MeSH Terms

Interventions

Endostatins

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 28, 2024
• Study Start: February 18, 2024
• Primary Completion: June 18, 2024
• Study Completion: December 18, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Half a year to one year after the start of the research
• Access Criteria: All can be accessed