Skip to content

An open-label,single-arm trial of HIPEC combined with Apatinib in patients with advanced peritoneal implantation tumor

An open-label,single-arm trial of HIPEC combined with Apatinib in patients with advanced peritoneal implantation tumor

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17013522
Enrollment
Unknown
Registered
2017-11-24
Start date
2017-11-27
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

peritoneal implantation tumor

Interventions

experimental group :Apatinib+HIPEC

Sponsors

Hangzhou Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Advanced peritoneal tumor confirmed by imaging examination (CT or MRI) (including but not limited to the gastric cancer, colon cancer, ovarian cancer,recurrence or metastasis in abdominal or peritoneal cavity), and the last treatment was at least 3 months ago; 2. Patients in failure with standard chemotherapy, and can not tolerate or without standard chemotherapy regimens available; 3. Patients who are willing to receive molecular targeted therapy and / or chemotherapy; 4. Aged more than 18 years old; 5. ECOG(Eastern Cooperative Oncology Group) :0~2; 6. The Expected lifetime:=12 weeks; 7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB=90 g/L, ANC>1.5×10^9/LPLT>100×10^9/L, TBIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value(Liver metastasis:<5×ULN), and CRE<1.2mg/dl 8. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 9. Signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Patients with extensive intra-abdominal adhesion caused by various causes; 2. Patients with anastomotic edema, ischemia, tension and other bad healing factors; 3. Patients with cachexia; 4. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms),Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 140 mmHg, diastolic blood pressure> 90 mmHg ); 6. Coagulant function abnormality (PT> 16 seconds,APTT> 43 seconds,TT> 21 seconds or Fbg<2g/L), with bleeding tendency or is treated with thrombolysis and anticoagulation 7. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc within 12 months before screening; 8. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month prior to study entry; 9. Patients with bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc within 3 months before screening; 10. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 11. Having a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 12. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 13. Having a history of psychiatric abuse and can not quit or have mental disorders; 14. Participated in other drug clinical researchers within four weeks; 15. Pregnant and lactating women; According to the researcher's judgment, there are serious illnesses that compromise the patient's safety or affect the patient's completion of the study.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
QoL;OS;DCR;

Countries

China

Contacts

Public ContactZhibing Wu

Hangzhou Cancer Hospital

wu_zhibing@163.com+86 13858065026

Outcome results

None listed

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