A prospective, multi-center, non-intervention study of human recombinant endostain injection durative transfusion combined with chemotherapy in the treatment of advanced malignant tumors

A prospective, multi-center, non-intervention study of human recombinant endostatin injection durative transfusion combined with chemotherapy in the treatment of advanced malignant tumors

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPN-17010673

Enrollment

Unknown

Registered

2017-02-18

Start date

2017-02-10

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

advanced malignant tumors

Interventions

treatment group:recombinant human endostatin combined with chemotheapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. male or female aged 18 to 75 years; 2. histologically or cytologically confirmed inoperable, recurrence and/or metastatic malignant solid tumor patients who can not be surgeried, recurrence and/or metastasis; 3. have at least one evaluable lesions satisfied the criteria in RECIST 1.1(measuring >=10mm on spiral CT scan,or enlarged lymph nodes short diameter >=15mm); 4. ECOG PS 0 or 2; 5. expected survival at least 3 months; 6. The main organ function, that meet the following criteria: (1) HB>=80 g/L; ANC>=1.5*10^9/L; PLT>=80*10^9/L; (2) TBIL 45 ml/min (Cockcroft-Gault formula); 7. ECG is normal; 8.The subjects voluntarily joined the study, and informed consent, good compliance, with the follow-up.

Exclusion criteria

Exclusion criteria: 1. local treatment have been carried out to target lesions (including local radiotherapy, intervention, ultrasound scalpel, etc.); 2. pregnancy, breast-feeding women, or female patients of childbearing potential but did not take contraceptive measures; 3. existing severe acute infection and is not controlled; or purulent and chronic infection, delayed healing wounds; 4. the original severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension; 5. have bleeding tendencies; 6. with mental illness or aids; 7. previous to biological agents, particularly E.coli genetically engineered products with serious allergic reactions; 8. received other drugs in clinical trials within 3 months; 9. other researchers believe that patients should not participate in the present trial.

Design outcomes

Primary

Measure	Time frame
TTP;ORR;DCR;	—

Secondary

Measure	Time frame
PFS;quality of life;	—

Countries

China

Contacts

Public ContactWenying Zhao

The First Affiliated Hospital of Wannan Medical College

zwy815@126.com+86 13505530069

Outcome results

None listed

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