Ramucirumab Combined With Nab-paclitaxel, Lobaplatin, and S-1 in Neoadjuvant Transformation Therapy for Advanced Gastric Cancer

NCT ID: NCT06169410

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-30
• Study Completion Date: 2025-12-31

Brief Summary

Abstract Objective: Ramucirumab is a VEGFR2 antagonist. The aim of this trial is to evaluate the efficacy and safety of ramucirumab combined with nab-paclitaxel, lobaplatin and S-1 in neoadjuvant and conversion therapy for advanced gastric cancer.

Methods and analysis: This study is a prospective single-center, randomized controlled and open label clinical study containing two cohorts with 140 patients of advanced gastric cancer (Cohort A n=70; Cohort B n=70). The main efficacy indicator is pathological complete response (pCR) of the cancer after neoadjuvant or conversion therapy. The secondary efficacy indicators are R0 resection rate after neoadjuvant or conversion therapy, the incidence of adverse events (AE), progression-free survival (PFS), overall survival (OS), objective response rate (ORR), total response rate and total response time, disease control rate (DCR) and duration of overall response (DOR).

Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20232220-F-1).

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ramucirumab combined with lobaplatin, S-1 and nab-paclitaxel

Patients will be given ramucirumab (8mg/kg), lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time; patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.

Group Type: EXPERIMENTAL

nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumab

Intervention Type: DRUG

Patients in Experimental group will be given ramucirumab (8mg/kg) by intravenous drip on the first day of each cycle, 3 weeks a cycle.

nab-paclitaxel, lobaplatin, and S-1

Intervention Type: DRUG

Patients will be given lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time. Patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.

lobaplatin combined with S-1 and nab-paclitaxel

Patients will be given lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time; patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.

Group Type: ACTIVE_COMPARATOR

nab-paclitaxel, lobaplatin, and S-1

Intervention Type: DRUG

Patients will be given lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time. Patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.

Interventions

nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumab

Patients in Experimental group will be given ramucirumab (8mg/kg) by intravenous drip on the first day of each cycle, 3 weeks a cycle.

Intervention Type: DRUG

nab-paclitaxel, lobaplatin, and S-1

Patients will be given lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time. Patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Cohort A: Patients are diagnosed with locally advanced gastric or gastroesophageal junction adenocarcinoma by cytology or histopathology and in need of preoperative neoadjuvant therapy to reduce recurrence and metastasis rates; Cohort B: Patients with advanced gastric cancer who have undergone surgery after neoadjuvant chemotherapy with previously used nab-paclitaxel, lobaplatin and S-1.

Patients are adults aged 18-75 years with an Eastern Cooperative Oncology Group(ECOG) performance status score less than or equals to 1.

Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy) .

Functions of the major organs and bone marrow meet the following criteria within 7 days before treatment: hemoglobin ≥ 80g/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet (PLT) ≥ 100× 109/L, without blood transfusion within 14 days, total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5x ULN or if complicated with liver metastasis then ALT and AST ≤ 5x ULN, serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 50mL/min or urinary protein<2+, activated partial thromboplastin time (APTT) and international standardized ratio (INR)≤1.5×ULN.

Expected lifespan ≥ 6 months. The patients are able and willing to provide written informed consent to participate in the study.

Exclusion Criteria

Patients who have previously suffered from other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ.

HER-2 positive patients who are willing to receive Herceptin treatment. Women who are pregnant or lactating or in the reproductive period and have not taken effective contraceptive measures, or those who have fertility requirements during the research period.

Patients with serious and uncontrolled internal diseases and infections or with chronic bowel disease or short bowel syndrome.

Patients with major organ failure, such as compensatory heart, lung, liver, and kidney failure as well as severe metabolic abnormalities in liver and kidney which affects normal drug metabolism.

Patients with a clear tendency for gastrointestinal bleeding and/or abnormal coagulation function (INR>1.5)under researchers evaluation.

hepatitis B virus or hepatitis C virus in active phase Patients with peripheral neuropathy neoadjuvant chemotherapy(NCT)-CTCAE ≥ Level 2.

-

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

Sponsors

Yang Jianjun, PhD

OTHER

Sponsor Role: lead

Responsible Party

Yang Jianjun, PhD

Professor from Xijing Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of the Air Force Medical University

Xi'an, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianjun Yang, professor

Role: CONTACT

yangjj@fmmu.edu.cn

86+029-84771532

Facility Contacts

Jianjun Yang

Role: primary

yangjj@fmmu.edu.cn

029-84771532

References

Wang J, Xu G, Liu S, Ma Y, Wang S, Li M, Zhao Y, Wang H, Wang Y, Peng C, Huo H, Li H, Ji G, Yang J. Evaluation of the efficacy and safety of ramucirumab combined with nab-paclitaxel, lobaplatin, and S-1 in neoadjuvant and conversion therapy for advanced gastric cancer: A study protocol of prospective single-center, randomized controlled and open label clinical trial (RNPLS-01). Heliyon. 2024 Apr 9;10(8):e29485. doi: 10.1016/j.heliyon.2024.e29485. eCollection 2024 Apr 30.

Reference Type: DERIVED

PMID: 38660276 (View on PubMed)

Other Identifiers

RNPLS-01

Identifier Type: -

Identifier Source: org_study_id