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Clinical study of Apatinib combined with docetaxel as second-line treatment in advanced gastric cancer

Clinical study of Apatinib combined with docetaxel as second-line treatment in advanced gastric cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17013834
Enrollment
Unknown
Registered
2017-12-11
Start date
2017-03-30
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

gastric cancer

Interventions

Sponsors

Shanxi Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years male and female; 2. Advanced gastric cancer confirmed by pathology; 3. First-line chemotherapy failure; 4. Advanced gastric cancer with measurable lesions (CT scan or MR Long diameter of tumor=10mm); 5. ECOG 0-2; 6. Estimated survival time=3 mouths; 7. The main organ function is normal, and meet the following standards: (1) The standard of blood routine examination should be consistent: WBC = 3.5×10^9/L, ANC = 1.5×10^9/L, HB= 80 g/L,PLT =70×10^9/L; (2) Biochemical tests should meet the following criteria: No hepatic metastasis, ALT = 52.5×ULN, with hepatic metastasisALT=5×ULN; 8. The wound healed completely without bleeding tendency after the operation; 9. 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. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 10. Patients voluntarily entered the study and signed informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg, diastolic pressure >90mmHg); 2. There are a variety of factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction etc); 3. Coagulopathy (INR>1.5×ULN; APTT>1.5×ULN), with Bleeding tendency; 4. Central nervous system metastasis with symptoms; 5. Pregnant or lactating women; 6. Other cases the researchers judged that could affect the outcome of the clinical study.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
Disease Control Rate;Overall survival;Objective Remission Rate;Safety;

Countries

China

Contacts

Public ContactMudan Yang

Shanxi Tumor Hospital

ahead-sxzl02@hotmail.com+86 138 0343 3331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026