Clinical Trials/NCT06415669

NCT06415669

Recruiting

Phase 2

A Study of Paclitaxel (Albumin-bound) Combined With Apatinib and Adebrelimab in the Treatment of Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma Following Previous Immunotherapy Progression

The First Affiliated Hospital of Xiamen University1 site in 1 country30 target enrollmentMay 19, 2024

ConditionsGastric/Gastroesophageal Junction Adenocarcinoma

InterventionsPaclitaxel for injection (albumin-bound)Adebrelimab Apatinib mesylate

DrugsPaclitaxel for injection (albumin-bound)Adebrelimab Apatinib mesylate

Overview

Phase: Phase 2
Intervention: Paclitaxel for injection (albumin-bound)
Conditions: Gastric/Gastroesophageal Junction Adenocarcinoma
Sponsor: The First Affiliated Hospital of Xiamen University
Enrollment: 30
Locations: 1
Primary Endpoint: Objective response rate（ORR）
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound) in combination with apatinib mesylate and adebrelimab in the treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the progression of previous immunotherapy.

Registry

clinicaltrials.gov

Start Date

May 19, 2024

End Date

May 19, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The First Affiliated Hospital of Xiamen University

Responsible Party

Principal Investigator

Mingquan Cai

Director of medical oncology

The First Affiliated Hospital of Xiamen University

Eligibility Criteria

Inclusion Criteria

•Age: 18 \~ 75 years old, male and female;
•ECOG score: 0 or 1;
•Patients with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology;
•Patients who have received at least first-line immunotherapy progression or intolerance in the past, and the number of previous systemic treatment lines does not exceed 2 lines; The best curative effect of frontline containing PD-1/PD-L1 was CR, PR or SD;
•According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy can also be selected as target lesions if progression is confirmed);
•The major organs function normally and meet the following criteria
•a. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109 /L;
•b. Platelets ≥100×109 /L in the past 14 days without blood transfusion;
•c. Hemoglobin \>90g/L in the last 14 days without blood transfusion or use of erythropoietin;
•d. Total bilirubin ≤1.5× upper limit of normal (ULN);

Exclusion Criteria

•Patients who have previously received paclitaxel chemotherapy; Patients with neoadjuvant or adjuvant treatment with taxoid drugs and disease progression more than 6 months after the last chemotherapy were excluded;
•HER2-positive patients;
•Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before enrollment;
•Patients with severe liver and kidney insufficiency or heart insufficiency;
•have multiple factors that affect oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
•Patients with brain metastases accompanied by symptoms or symptom control for less than 3 months;
•Patients who are known to be allergic to any investigational drug or drug excipient;
•Pregnant or lactating female patients;
•Patients who underwent major surgical procedures (craniotomy, thoracotomy, or laparotomy) or had unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to initial dosing, except for patients ≥2 weeks after surgery and patients with old fractures that the investigator determined could be treated with the study drug;
•Patients with moderate to severe ascites accompanied by clinical symptoms requiring repeated drainage; Patients with uncontrolled or clinical symptoms of pleural effusion or pericardial effusion;

Arms & Interventions

Single arm

Paclitaxel for injection (albumin-bound) in combination with Apatinib mesylate and adebrelimab

Intervention: Paclitaxel for injection (albumin-bound)

Single arm

Paclitaxel for injection (albumin-bound) in combination with Apatinib mesylate and adebrelimab

Intervention: Adebrelimab

Single arm

Paclitaxel for injection (albumin-bound) in combination with Apatinib mesylate and adebrelimab

Intervention: Apatinib mesylate

Outcomes

Primary Outcomes

Objective response rate（ORR）

Time Frame: 1 years

Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.

Secondary Outcomes

Disease control rate（DCR）(1 years)
Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR) Duration of response (DoR)(1 years)
Progression-free survival (PFS)(1 years)
Overall survival（OS）(2 years)
Occurence of AE and SAE(2 years)
Appraisal of life quality(1 years)