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A clinical study for recombinant human vascular endostatin intravenous injection combined with chemotherapy in the treatment of exogenous recurrent metastatic head and neck malignant tumor

A clinical study for recombinant human vascular endostatin intravenous injection combined with chemotherapy in the treatment of exogenous recurrent metastatic head and neck malignant tumor

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022364
Enrollment
Unknown
Registered
2019-04-08
Start date
2019-04-15
Completion date
Unknown
Last updated
2019-04-15

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

Conditions

Head and Neck Malignancies

Interventions

3:Chemotherapy + intravenous injection of recombinant human vascular endostatin (30mg/ m, d1-7 daily). The needle was injected at 0.5cm subcutaneously at the outer edge of the tumor body, and then the
2:Chemotherapy + recombinant human endostatin was pumped into the group (recombinant human endostatin 30mg/ m, d1-d7). Recombinant human endostatin was added into normal saline and made into 220ml, us
1:Chemotherapy alone group (chemotherapy docetaxel 75 mg/ m,d1, cisplatin 30mg/ m,d1-3)

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) all patients were diagnosed with head and neck squamous cell carcinoma by head and neck CT examination and histological cytology; 2) male or female, aged > 18 years and 50%; 6) the subjects voluntarily received recombinant human vascular endostatin treatment with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1) patients who participated in other clinical trials within 4 weeks before treatment; 2) those who are not expected to be able to tolerate the test; pregnant and lactating women; 3) patients with psychological diseases cannot cooperate with the study; 4) patients with central nervous system diseases or related medical history (such as primary brain tumors, tumor-related apoplexy, cancerous meningitis, and metastatic tumors not under control); The expected survival time with brain metastasis or advanced disease is less than 3 months; 5) the tumor has obvious local ulceration and bleeding, and there are infected people who are active or cannot be controlled.

Design outcomes

Primary

MeasureTime frame
OS;PFS;

Secondary

MeasureTime frame
DCR;ORR;QOL;

Countries

China

Contacts

Public ContactLiu Ping
CYRIL0820@sina.com+86 15084987287

Outcome results

None listed

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