A Study of HIPEC Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

H

Hebei Medical University

Status and phase

Not yet enrolling
Phase 2

Conditions

Gastric Cancer

Treatments

Drug: paclitaxel apatinib S-1

Study type

Interventional

Funder types

Other

Identifiers

NCT03428425
HRA-G02

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of HIPEC plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells

Enrollment

38 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy); 2. Age:18 to 70 years old; 3. Man or female (except pregnant and lactating women); 4. Confirmed to gastric adenocarcinoma; 5. Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive; 6. Blood cell count has to meet the following certeria: WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L; 7. Liver/kidney function has to meet the following certeria: ALT and AST≤2.5×ULN TBIL<1.5×ULN; Serum creatinine ≤1.5×ULN; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 9. Participants were willing to join in this study, good adherence and written informed consent.

Exclusion criteria

- 1. Patients with other malignant tumors within 5 years; 2. Metastasis was found to be visible to the naked eye; 3. It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on); 4. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 5. Patients with severe or uncontrollable mental illness; 6. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months; 7. Pregnant or lactating women; 8. It have serious harm to the patient's safety or affect the patients who have completed the research.

9. The researchers think inappropriate.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

apatinib paclitaxel S-1
Experimental group
Treatment:
Drug: paclitaxel apatinib S-1

Trial contacts and locations

0

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Central trial contact

Qun Zhao

Data sourced from clinicaltrials.gov

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