Study of continuous intravenous infusion of rh-endostatin for three days in the combination chemotherapy of advanced NSCLC with negative driver gene mutation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064150

Enrollment

Unknown

Registered

2022-09-27

Start date

2022-09-30

Completion date

Unknown

Last updated

2023-04-17

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

Experimental Group:continuous intravenous infusion of rh-endostatin for three days in the combination chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily participate in this study and sign informed consent; 2. Aged 18-80 years, PS score 0 ~ 2; 3. Histologically or cytologically confirmed negative driver genes (EGFR, ALK, ROS1) in local or advanced NSCLC (stage IIIB, stage IIIC Or stage IV); 4. Measurable lesions in the lungs; 5. Initial treated patients who have not received prior systematic antitumor therapy, including radiotherapy and chemotherapy, targeted and immunotherapy, or patients with recurrence after follow-up of more than 6 months after adjuvant chemotherapy; 6. Expected survival > 3 months.

Exclusion criteria

Exclusion criteria: 1. Allergic reaction to any component contained in recombinant human endostatin or antibody preparations; 2. Systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors, or immunotherapy, is planned within 4 weeks prior to enrollment or during the duration of the study (or prior use of mitomycin C within 6 weeks prior to receiving the study drug); 3. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment; 4. Patients with any physical signs or history of bleeding, regardless of severity; Any bleeding or bleeding event >= CTC-AE grade 3 in the 4 weeks prior to enrollment, unhealed wounds, ulcers, or fractures; 5. Patients with major organ dysfunction and serious heart disease, including congestive heart failure, uncontrolled arrhythmia, angina pectoris requiring long-term medication, valvular heart disease, myocardial infarction, and refractory hypertension; 6. Pregnant or lactating women; 7. Comorbidities that, in the investigator's judgment, seriously endanger the patient's safety or prevent the patient from completing the study.

Design outcomes

Primary

Measure	Time frame
Ojective remission rate;	—

Secondary

Measure	Time frame
Progression-Free Survival;Overall survival;safety;Pharmacokinetics;	—

Countries

China

Contacts

Public ContactMin Zhang

Shanghai General Hospital

maggie_zhangmin@163.com13482345145

Outcome results

None listed

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