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Study of convernsion therapy using SOX chemotherapy plus Apatinib in local advanced or metastatic gastric cancer

Study of convernsion therapy using SOX chemotherapy plus Apatinib in local advanced or metastatic gastric cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17012564
Enrollment
Unknown
Registered
2017-09-04
Start date
2017-09-06
Completion date
Unknown
Last updated
2017-09-11

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:S-1+ oxaliplatin+aptinib

Sponsors

Zhejiang Province People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of primary gastric adenocarcinoma; 2. Definitely diagnosed as unresectable gastric cancer before operation via CT, MRI or PET-CT: Group1: N3 lymph node metastasis; Group2: Extensive or bulcky lymph nodes,highly locally advanced T4; Group3: extensive metastasis to hepatocyte (H1): not more than three metastatic foci of radical excision,the total diameter =8cm Group4: Peritoneal metastasis(CY1,P1,P2); Group5: Ovarian metastasis(kukerburg tumor); 3. Definitely diagnosed as above stage of gastric cancer before operation through the laparoscopic exploration if necessary; 4. No other antineoplastic treatment (Radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc); 5. ECOG (Eastern Cooperative Oncology Group) 0~2; 6. Aged 18~75 years old, the Expected lifetime =3 month; 7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: WBC>4.0*10^9/L, ANC>1.5×10^9/LPLT>100×10^9/L, BIL<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. Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease; 9. Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver); 10. Not participating in other clinical trials 4 weeks before and during the treatment; 11. Signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Distal metastasis to lung, brain, and bone but liver 2. Her-2 test was positive and willing to receive Hessaitin treatment 3. Operation intolerance due to other uncontrolled diseases(Including atrial fibrillation, angina pectoris, cardiac dysfunction, ejection fraction less than 50%, refractory hypertension, and renal dysfunction) 4. Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment 5. Allergy to the drugs in this protocol 6. Pregnant and lactating women 7. Women at childbearing age and of pregnancy desire during the study 8. Any medical or other condition that in the opinion of the investigator would preclude the subjects participation in a clinical study.

Design outcomes

Primary

MeasureTime frame
radical resection rate;pathological remission rate;

Countries

China

Contacts

Public ContactMou Yiping, Yang Liu

Zhejiang Province People's Hospital

winter6868@163.com+86 13666601475

Outcome results

None listed

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