A Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer

• Status: Unknown status
• Trial end date: 2021-10-22
• Target enrollment: 0
• Participant gender: All

Summary

The prognosis of Extensive lymph nodes metastatic(ELM) gastric cancer is poor. Chemotherapy occasionally converts it to a resectable cancer. Previous studies showed patients with ELM gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of ELMGC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. On the basis of our previous Ahead-G325 study, The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of ELM gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Collaborators: Fujian Cancer Hospital; Zhejiang Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• ELM gastric cancer as proven histologically under following condition: unable radical excision due to the abdominal aorta a2-b1 or extensive lymph nodes metastatic,

• Definitely diagnosed as above stage of gastric cancer before operation via CT of MRI, ultrasonic endoscopy, PET-CT, or through the laparoscopic exploration if necessary

• Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)

• Negative HER-2 state

• ECOG(Eastern Cooperative Oncology Group): 0~2

• Age: 18~70 years old- survival time > 3monts

• Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: WBC>4.0*109/ L, NE>1.5*109/L, PLT>100*109/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, and CRE<1.2mg/dl

• Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease

• Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)

• Not participating in other clinical trials before and during the treatment

• Signed the Informed Consent Form

• No peritoneal metastatic and CY0 in 28 days by laparoscopic exploration

• Non-gastric stump cancer

• No esophagus infiltrating or infiltrating less than 3cm

Exclusion Criteria:

• Distal metastasis to Mediastinal lymph node,liver ,peritoneal,pleural effusion ,ascites,above 16a2-b1 and others

• Severe mental illness

• Her-2 positive, desire for hercptin treatment

• Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment

• Allergy to the drugs in this protocol

• Pregnant and lactating women

• Women at childbearing age and of pregnancy desire during the study