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A multicenter real-world study on the efficacy and safety of recombinant human endostatin combined with chemotherapy and PD-1/PD-L1 first-line treatment in non-surgical NSCLC patients

A multicenter real-world study on the efficacy and safety of recombinant human endostatin combined with chemotherapy and PD-1/PD-L1 first-line treatment in non-surgical NSCLC patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085777
Enrollment
Unknown
Registered
2024-06-18
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non small cell lung cancer

Interventions

endostar+chemotherapy: During the treatment phase, recombinant human endostatin (Endostar)+chemotherapy should be administered for at least 4 cycles
Endostatin maintenance therapy until disease progression or intolerable toxicity):None
endostar+PD-1/PD-L1: During the treatment phase, recombinant human endostatin (Endostar)+PD-1/PD-L1 is administered for 4 cycles, followed by maintenance therapy with either Endostatin or PD-1/PD-L1 a
(The specific maintenance treatment plan is determined by the researcher):None
endostar+chemotherapy+PD-1/PD-L1: During the treatment phase, recombinant human endostatin (endostar)+chemotherapy+PD-1/PD-L1 is administered for 4 cycles, followed by maintenance or monotherapy with

Sponsors

Jiaozuo People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) = 18 years old; Both men and women are eligible 2) Patients with non-surgical NSCLC confirmed by histology or cytology have a negative driver gene test status; 3) ECOG physical condition score is 0-2 points 4) According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion as the target lesion, and the measurable lesion should not have received local treatment such as radiotherapy;

Exclusion criteria

Exclusion criteria: 1) Individuals with hypertension who cannot be controlled by antihypertensive medication treatment; 2) Urine routine shows protein positivity++; 3) Abnormal coagulation function, active hemoptysis requiring clinical intervention, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis; 4) 3-4 levels of cardiac dysfunction (NYHA standard); 5) Patients with severe liver and kidney dysfunction (grade 4); 6) Known to have hypersensitivity reactions to any component contained in Endu or antibody preparations; 7) Patients diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study are not eligible for enrollment. Patients who use physiological doses of glucocorticoids (= 10mg/day of prednisone or equivalent drugs) are eligible for enrollment; 8) Subjects with type I diabetes, hypothyroidism only requiring hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or who are not expected to reappear without external triggers can be selected; 9) Individuals with pre-existing severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, and severe heart valve disease; 10) There is active hepatitis B (HBV DNA = 2000IU/ml or 104 copies/ml), hepatitis C (Hepatitis C antibody positive, and HCV-RNA above the detection limit of the analytical method). 11) 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; 12) 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; 13)Researchers believe there are contraindications to inappropriate medication

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Overall survival;Progression-free survival;Duration of Response;

Countries

China

Contacts

Public ContactHuangfu Juan

Jiaozuo People's Hospital

huangfj1976@yeah.net+86 139 3911 3142

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026