A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma

NCT06415669 | Recruiting Phase 2

• 1 other identifier: 23-OBU-FJ-GC-II-013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric/Gastroesophageal Junction Adenocarcinoma

Keywords

paclitaxel; apatinib; adebrelimab; adenocarcinoma of the gastroesophageal junction; gastric carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate（ORR）

  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.

  1 years

Secondary Outcomes (6)

• Disease control rate（DCR）

  1 years

• Progression-free survival (PFS)

  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

• Overall survival（OS）

  2 years

• Occurence of AE and SAE

  2 years

Other Outcomes (1)

• Explore potential biomarkers in tumor tissue

  1 years

Study Arms (1)

Single arm

EXPERIMENTAL

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

Drug: Paclitaxel for injection (albumin-bound); Drug: Adebrelimab; Drug: Apatinib mesylate

Interventions

Paclitaxel for injection (albumin-bound) DRUG

100 mg/m2, day 1, day 8, every 21 days for a cycle.

Single arm

Adebrelimab DRUG

20mg/kg or 1200mg, the first day, every 21 days as a cycle.

Also known as: SHR-1316

Single arm

Apatinib mesylate DRUG

250mg once a day for 5 consecutive days and discontinue for 2 days

Single arm

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: 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);
• e. aspartate aminotransferase (AST), alanine aminotransferase (ALT) in
• ≤2.5×ULN (ALT or AST ≤5×ULN for patients with liver metastasis);
• f. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min;
• g. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
• h. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included);

You may not qualify if:

• \) 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;
• \) Patients with clinically significant electrolyte disorders;
• \) People with acute or chronic active hepatitis B or hepatitis C: hepatitis B virus (HBV) DNA \> 2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA \> 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive patients;
• \) Patients with central nervous system metastasis, but with no clinical symptoms or accompanied by clinical symptoms after treatment, disease control and stable time ≥4 weeks can be enrolled; To meet the need for measurable lesions outside the central nervous system, hormone therapy should be discontinued 14 days before the first study of medication
• \) Any life-threatening bleeding event within the previous 3 months, including patients requiring transfusion therapy, surgery or local therapy, and ongoing medication;
• \) Patients with a history of arteriovenous thromboembolism events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism within the past 6 months. The exception is implantable intravenous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, which is stable after conventional anticoagulant therapy. Allow patients to prophylactically use small doses of low molecular weight heparin (e.g., enoxaparin 40 mg/ day);

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; Injections; apatinib

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; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mingquan Cai

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• Xia Lv

  Xiamen Humanity Hospital

  PRINCIPAL INVESTIGATOR

• Jun Qiu

  Xiamen Humanity Hospital

  PRINCIPAL INVESTIGATOR

• Huita Wu

  Zhongshan Hospital Affiliated to Xiamen University

  PRINCIPAL INVESTIGATOR

• Xiuping Zhang

  Zhongshan Hospital (Xiamen), Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaojian Yin

  Xiamen Changgeng Hospital

  PRINCIPAL INVESTIGATOR

• Jinfeng Zhu

  Quanzhou First Hospital

  PRINCIPAL INVESTIGATOR

• Wen Chen

  The Second Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Yijun Wang

  Zhangzhou Hospital

  PRINCIPAL INVESTIGATOR

• Guoqin Qiu

  The 73rd Army Hospital

  PRINCIPAL INVESTIGATOR

• Yongmei Liu

  West China Xiamen Hospital of Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingquan Cai

CONTACT

13696908231; mingquan035@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of medical oncology

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 16, 2024
• Study Start: May 19, 2024
• Primary Completion: May 19, 2026
• Study Completion (Estimated): May 19, 2027
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)