Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy

NCT ID: NCT06279754

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-18
• Study Completion Date: 2025-12-18

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.

Detailed Description

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.

Patients with locally advanced stage III squamous non-small cell lung cancer who have not received systematic treatment in the past and cannot be treated surgically, after signing informed consent, qualified subjects who meet the inclusion criteria will be screened. They will receive 2 cycles of recombinant human endostatin combined with envafolimab and platinum containing chemotherapy. Radiotherapy will be carried out simultaneously in cycles 1-2, and after 2 cycles, they will receive maintenance treatment with envafolimab until the disease progresses and intolerable toxicity is detected, The treatment period does not exceed 12 months

Conditions

Locally Advanced Squamous Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

recombinant human endostatin Group

Recombinant human endostatin and enrolizumab injection combined with Synchronal Radiochemotherapy

Group Type: EXPERIMENTAL

Recombinant Human Endostatin Injection

Intervention Type: 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

Interventions

Recombinant Human Endostatin Injection

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

Intervention Type: DRUG

Other Intervention Names

Evafolimab Injection

Eligibility Criteria

Inclusion Criteria

• 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.
• 18-70 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.

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xinxiang Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ZLXGBXKYXM-031-01

Identifier Type: -

Identifier Source: org_study_id