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

NCT ID: NCT04047953

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conversion Therapy

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Paclitaxel (albumin-bound) + Oxaliplatin + S-1; Nab-paclitaxel + Oxaliplatin + S-1

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Zhaode Bu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiafu ji, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Zhaode Bu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiafu ji, MD

Role: CONTACT

jiafuj@hotmail.com

86-010-88196048

Zhaode Bu, MD

Role: CONTACT

buzhaode@cjcrcn.org

86-010-88196945

Facility Contacts

Jiafu Ji, MD

Role: primary

jiafuj@hotmail.com

86-010-88196048

Zhaode Bu, MD

Role: backup

buzhaode@cjcrcn.org

86-010-88196945

Other Identifiers

GC-conversion

Identifier Type: -

Identifier Source: org_study_id