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

NCT04047953 | Recruiting

• 1 other identifier: GC-conversion
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Adenocarcinoma

Keywords

Paclitaxel (albumin-bound); gastric cancer; conversion therapy

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Proportion of patients who achieved R0 resection

  within 4 weeks following the operation

Secondary Outcomes (3)

• Progression free survival (PFS)

  5 years

• overall survival (OS)

  5 years

• Adverse Events(AEs)

  until 28 days after the last study drug administration

Study Arms (1)

Conversion Therapy

EXPERIMENTAL

Paclitaxel (albumin-bound) +S-1+Oxaliplatin

Drug: Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1

Interventions

Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1 DRUG

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.

Also known as: Paclitaxel (albumin-bound) + Oxaliplatin + S-1, Nab-paclitaxel + Oxaliplatin + S-1

Conversion Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; Oxaliplatin; S 1 (combination); 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Jiafu ji, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Zhaode Bu, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiafu ji, MD

CONTACT

86-010-88196048; jiafuj@hotmail.com

Zhaode Bu, MD

CONTACT

86-010-88196945; buzhaode@cjcrcn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: September 10, 2019
• Primary Completion: December 31, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

CN (1)