Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma

The Study of Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Initial Unresectable Local Advanced or Potentially Resectable Metastatic Gastric Adenocarcinoma

To evaluate the efficacy and safety of Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 conversion therapy for initial unresectable local progression or potential resectable metastatic gastric adenocarcinoma.

Study Overview

• Status: Recruiting
• Conditions: Gastric Adenocarcinoma
• Intervention / Treatment: Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1

• Study Type: Interventional
• Enrollment (Anticipated): 95
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiafu Ji, MD; Phone Number: 86-010-88196048; Email: jiafuj@hotmail.com
• Study Contact Backup: Name: Zhaode Bu, MD; Phone Number: 86-010-88196945; Email: buzhaode@cjcrcn.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Cancer Hospital
      • Principal Investigator: Jiafu Ji, MD
      • Contact: Jiafu Ji, MD; Phone Number: 86-010-88196048; Email: jiafuj@hotmail.com
      • Contact: Zhaode Bu, MD; Phone Number: 86-010-88196945; Email: buzhaode@cjcrcn.org
      • Principal Investigator: Zhaode Bu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age of 18-75 years; male or female.
• Karnofsky Performance Status Score ≥70.
• Histological diagnosis of gastric adenocarcinoma, HER2 expression negative.
• The initial unresectable locally advanced or potentially resectable metastatic gastric adenocarcinoma, potentially resectable factor includes a single liver metastases, localized abdominal para-aortic lymph node (16a1 / b2) metastasis or positive abdominal free cancer cells.
• Physical condition and organ function allow for larger abdominal surgery.
• Subject baseline blood routine and blood biochemistry indexes meet the following criteria: hemoglobin(HB) ≥90 g/L; absolute neutrophil count(ANC) ≥1.5×109 /L; platelet count(PLT) ≥100×109 /L; alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN); total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN); Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); Serum albumin≥30g/L.
• Echocardiographic scan confirmed left ventricular ejection fraction (LVEF) ≥ 50%.
• No serious accompanying disease lead to a survival period of <5 years.
• Agree and be able to follow the protocol during the study period.
• Written informed consent was provided prior to the study screening and the patient was informed that the study could be withdrawn at any time during the study without any loss.

Exclusion Criteria:

• For the treatment of the gastric cancer, patients who have received cytotoxic chemotherapy, radiotherapy or immunotherapy, except corticosteroids.
• Pregnancy or breastfeeding woman.
• Women of childbearing age who had a positive pregnancy test at baseline or who did not undergo a pregnancy test. Menopausal women must be stopped for at least 12 months to ensure that no pregnancy is possible.
• Men and women who have sex (with fertility probability) are reluctant to contraception during the study.
• Patients with ascites and positive abdominal free cancer cells.
• There are other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
• Those with a history of epilepsy, central nervous system disease, or mental disorder may be judged by the investigator that their clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
• Clinically severe (active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe drug-affected arrhythmias, or there is a history of myocardial infarction in the last 12 months.
• Upper gastrointestinal stagnation or abnormal physiological function or malabsorption syndrome may affect the absorption of S-1.
• It is known to have peripheral neuropathy ≥ NCI CTC AE grade 2. However, only the deep sputum reflex (DTR) disappears and the patient does not have to be excluded.
• Organ transplantation requires immunosuppressive therapy.
• Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases.
• Moderate or severe renal impairment [creatinine clearance equal to or lower than 50ml/min (calculated according to Cockcroft and Gault equations), or serum creatinine > upper normal limit (ULN).
• Those suffering from dihydropyrimidine dehydrogenase (DPD) deficiency are known.
• Those who are allergic to taxanes or any research ingredients.
• Those who received research medications or preparations/treatments (ie, participated in other trials) within 4 weeks prior to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Conversion Therapy; Paclitaxel (albumin-bound) +S-1+Oxaliplatin

Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1; Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40~60mg，bid, d1-14( BSA<1.25m2，40mg；1.25m2≤BSA≤1.5m2，50mg；BSA>1.5m2，60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD and decided by the investigator to continue the treatment for two cycles or directly.; Other Names: Paclitaxel (albumin-bound) + Oxaliplatin + S-1; Nab-paclitaxel + Oxaliplatin + S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection rate	Proportion of patients who achieved R0 resection	within 4 weeks following the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	the time from registration to the date of disease progression or death resulting from any cause.	5 years
overall survival (OS)	the time from registration to the date of death resulting from any cause or the last follow-up visit.	5 years
Adverse Events(AEs)	AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.	until 28 days after the last study drug administration

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Jiafu Ji, MD, Peking University Cancer Hospital & Institute; Principal Investigator: Zhaode Bu, MD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: gastric cancer; conversion therapy; Paclitaxel (albumin-bound)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Oxaliplatin; Albumin-Bound Paclitaxel
• Other Study ID Numbers: GC-conversion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No