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Clinical study of apatinib combined with standard chemotherapy for advanced gastric cancer

Clinical study of apatinib combined with standard chemotherapy for advanced gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048149
Enrollment
Unknown
Registered
2021-07-04
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

gastric cancer

Interventions

Case series:No

Sponsors

Linfen Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Advanced gastric or gastroesophageal junction adenocarcinoma diagnosed by pathology with measurable lesions (spiral CT scan >=10mm, meeting RECIST 1.1 criteria); 3. ECOG PS: 0-2 points; 4. Main organs function normally and meet the following requirements: (1) Routine blood examination, must meet (no blood transfusion within 14 days) : 1) HB 80 g/L or higher; 2) The ANC acuity 1.5 x 10^9 / L; 3) PLT acuity 80 x 10^9 / L. (2) Biochemical examination shall meet the following standards: 1) BIL=50ml/min (Cockcroft-Gault formula). 5. Expected survival >=3 months; 6. The operation has been performed for more than 4 weeks and the wound has completely healed; 7. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib;For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last administration of apatinib tablets; 8. Patients voluntarily participated in this study and signed informed consent (ICF) with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure >140 mmHg/diastolic blood pressure > 90 mmHg), coronary heart disease (>=ii), arrhythmias (including QTC extended > 450 ms in men and > 470 ms in women) and cardiac insufficiency; 2. There are many factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 3. Abnormal coagulation function and bleeding tendency; 4. Symptomatic central nervous system metastases; 5. Pregnant or lactating women; 6. Other patients deemed unsuitable for inclusion by physicians.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Countries

China

Contacts

Public ContactLi Yanli

Linfen Central Hospital

458597129@qq.com+86 18360688809

Outcome results

None listed

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