First-line Apatinib Combined With Tislelizumab and Chemotherapy for Advanced GC

NCT06238752 | Completed Phase 2 DMC

• 1 other identifier: WDRY2022-K097
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

In this clinical study, investigators explore the efficacy and safety of a combination therapy regimen with antiangiogenic agent (apatinib), ICI (tislelizumab), and chemotherapy (capecitabine+ Oxaliplatin, XELOX) as first-line treatment for HER2-negative, advanced G/GEJ cancer patients with signet ring cell carcinoma or peritoneal metastasis.

Conditions

Advanced Gastric Adenocarcinoma

Keywords

Apatinib; Tislelizumab; Chemotherapy; Advanced; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  through study completion, an average of 1 year

Study Arms (1)

first-line treatment with the combination of apatinib, immune checkpoint inhibitor and chemotherapy

EXPERIMENTAL

Patients received 8 cycles of apatinib (250 mg, qd, d1-14), tislelizumab(200 mg d1), and oxaliplatin (130 mg/m2, d1) plus oral capecitabine (1000 mg/m2, bid, d1-14) every 3 weeks, with a maintenance therapy with apatinib plus tislelizumab for a maximum of 1 year. Homogeneous patients receiving ICIs combined with chemotherapy at the same time were deemed as the control group for efficacy.

Drug: Apatinib Combined With Tislelizumab and Chemotherapy

Interventions

Apatinib Combined With Tislelizumab and Chemotherapy DRUG

apatinib (250 mg, qd, d1-14), tislelizumab(200 mg d1), and oxaliplatin (130 mg/m2, d1) plus oral capecitabine (1000 mg/m2, bid, d1-14) every 3 weeks

Also known as: Combined therapy

first-line treatment with the combination of apatinib, immune checkpoint inhibitor and chemotherapy

Eligibility Criteria

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

You may qualify if:

• Sex: Men and women
• Age (at the time of informed consent): 18 years and older
• Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been istologically confirmed to be adenocarcinoma and has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer).For patients who have received neoadjuvant or adjuvant chemotherapy (including chemoradiotherapy) in combination with curative or endoscopic surgery (R0 resection confirmed), the chemotherapy in the last regimen must be completed by at least 180 days before the date of recurrence.
• Have at least one measurable lesion, as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1), on computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days before enrolled in the study
• Able to provide tumor tissue specimens (archival or fresh biopsy specimens) for PD-L1 expression analysis. For patients who are unable to undergo another biopsy, archival specimens may be used as an alternative.
• ECOG PS score 0 or 1
• Have a life expectancy of at least 3 months
• Have latest laboratory data meeting the criteria below within 7 days before enrolled. If the date of the laboratory tests at enrolled is not within 7 days before the first dose of the therapy regimen, testing should be repeated within 7 days before the first dose of the therapy regimen, and the latest laboratory data before the first dose of the therapy regimen must be confirmed to meet the following criteria. Moreover, laboratory data will not be valid if the patient has received a granulocyte colony stimulating factor (G-CSF) or blood transfusion within 14 days before testing.
• White blood cells ≥3000 cells per μL, and neutrophil count ≥1000 cells per μL
• Platelets ≥70 000 per μL
• haemoglobin ≥80 g/L
• Aspartate aminotransferase (AST) and alanine aminotransferase ≤3 times the limit of normal (ULN) or ≤5 times the ULN in patients with liver metastases
• Total bilirubin ≤1.5 times the ULN
• International Normalized Ratio (INR) ≤1.5
• Creatinine ≤1.5 times the ULN or creatinine clearance \>30 mL/min

You may not qualify if:

• Patients with HER2-positive or indeterminate gastric cancer (Determination for positive is made on the basis of the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry \[IHC\], or 2+ by IHC and positive by in situ hybridization \[ISH\]).
• multiple cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial bladder cancer, and any other cancers that have not recurred for at least 5 years)
• previous treatment with ICIs, chemotherapy or anti-angiogenic drug
• interstitial lung disease or pulmonary fibrosis
• Have concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease. Patients with Type 1 diabetes mellitus, hypothyroidism which is manageable by hormone replacement or skin disorders not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia) are permitted to be enrolled.
• Unable to take oral medicines
• Have a current or past history of severe hypersensitivity to any other antibody products
• Have concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
• Have experienced a transient ischemic attack, cerebrovascular accident, thrombosis or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before enrolled
• Have a history of uncontrollable or significant cardiovascular disease meeting any of the following;
• myocardial infarction within 180 days before randomization
• uncontrollable angina pectoris within 180 days before randomization
• arrhythmia requiring treatment
• Are receiving or require anticoagulant therapy (other than antiplatelet therapy including low dose aspirin) for a disease
• Have uncontrollable diabetes mellitus

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin hosptial of Wuhan University

Wuhan, Hubei, 430060, China

Location

MeSH Terms

Conditions

Adenocarcinoma

Interventions

tislelizumab; Drug Therapy; Psychotherapy, Multiple

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yuan Chen

  Renmin Hospital of Wuhan University

  STUDY CHAIR

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: prof

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 2, 2024
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: yongshun2007@163.com

Locations

CN (1)