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Clinical study of apatinib combined with chemotherapy and TACE ± microwave ablation/particle implantation in the treatment of liver metastasis of advanced gastrointestinal cancer

Clinical study of apatinib combined with chemotherapy and TACE ± microwave ablation/particle implantation in the treatment of liver metastasis of advanced gastrointestinal cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043919
Enrollment
Unknown
Registered
2021-03-05
Start date
2021-03-05
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

Gastrointestinal liver metastasis

Interventions

single:Non-intervention study

Sponsors

The First Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Be older than 18 years old and less than or equal to 90 years old; 2. Patients with liver metastases from advanced gastric and intestinal cancer diagnosed histologically or cytologically; 3. ECOG physical condition score 0-2; 4. Expected survival >= 12 weeks; 5. At least one measurable lesion [spiral CT/MRI scan >= 10 mm (CT scan thickness no greater than 5mm)] (RECIST version 1.1); 6. The functions of vital organs meet the following requirements: (1) Absolute neutrophils count (ANC) >= 1.5 x 10^9/L; (2) Platelet >= 75 x 10^9/L; (3) hemoglobin >= 80g/L; (4) Serum albumin >= 28g/L; (5) Total bilirubin = 50mL/min; (7) Normal thyroid function. (8) Sufficient cardiac function, left ventricular ejection fraction (LVEF) > 50% in two-dimensional cardiac ultrasound test. 7. No serious complications, such as uncontrolled hypertension, serious coronary heart disease and history of mental illness, no history of serious allergy; 8. Women of childbearing age must have used reliable contraceptive methods or had a pregnancy test prior to enrolment; 9. Subjects volunteered to participate in this study.Signed informed consent, good compliance, with follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to apatinib (active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrolled hypertension within 30 days after major surgery, grade III-IV cardiac insufficiency, severe liver and kidney dysfunction, etc.); 2. Abnormal coagulation function (INR >1.5 or prothrombin time (PT) BBB>N +4 s or APTT BBB2 1>LN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 3. Routine urine indicated that urine protein >= ++, or confirmed that 24-hour urine protein volume >= 1.0g; 4. Pregnant or lactating women; 5. The investigator judges other circumstances that may affect the conduct of the clinical study and the judgment of the study results.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Countries

China

Contacts

Public ContactYongfan Xin

The First Hospital of Shanxi Medical University

458597129@qq.com+86 18360688809

Outcome results

None listed

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