A prospective, positive, single-center, open clinical study for apatinib mesylate as first-line maintenance therapy for advanced pancreatic cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1800019969

Enrollment

Unknown

Registered

2018-12-10

Start date

2019-01-01

Completion date

Unknown

Last updated

2018-12-18

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

Conditions

pancreatic cancer

Interventions

experimental group:Apatinib+Chemotherapy with gemcitabine

control group:Chemotherapy with gemcitabine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years male and female; 2. Pathologically confirmed pancreatic cancer; 3. ECOG 0-2; 4. Espected survival time=3 mouths; 5. Confirmed by pathology with measurable lesions, (CT scan Long diameter of tumor=10mm, CT scan Long diameter of lymph node lesion=15mm, scan slice thickness>5mm); 6. The main organ function is normal, and meet the following standards: (1) The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=80×10^9/L; (2) Biochemical tests should meet the following criteria: BIL45ml/min; 7. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 8. Patients voluntarily entered the study and signed informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg, diastolic pressure >90mmHg); 3. Variety of factors affecting oral drugs (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 4. Coagulopathy (INR>1.5×ULN APTT>1.5×ULN), with Bleeding tendency; 5. Urinary protein is more than + + and confirmed the 24 hour urinary protein quantitative>1g; 6. Received apatinib or other VEGFR inhibitors, such as bevacizumab, Solafinib, Sunitinib; 7. Metastases of the central nervous system with symptoms; 8. Other cases the researchers judged that could affect the outcome of the clinical study.

Design outcomes

Primary

Measure	Time frame
PFS;	—

Secondary

Measure	Time frame
ORR;DCR;OS;	—

Countries

China

Contacts

Public ContactHan Yu

The Cancer Hospital of Harbin Medical University

834287905@qq.com+86 18645011168

Outcome results

None listed

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