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The Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer | Clinical Trials | Clareo Health

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The Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer

Prospective, Dual Arm, Open Ib/II Phase Clinical Study of the Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer

NCT06592287•Xianglin Yuan

View on ClinicalTrials.gov

Summary

This study is a prospective, dual arm, open Ib/II phase clinical trial, with the main objective of exploring the safety and efficacy of Adebrelimab combined with Apatinib and Lrinotecan liposome for second-line treatment of advanced gastric cancer. The study is divided into two stages. The first stage is the safety introduction period, which includes 6 patients. Observe whether the subjects experience dose limiting toxicity (DLT) during the observation period. If no subjects experience DLT during the observation period, the study enters the next stage. The dose of Lrinotecan liposome used during the safety introduction period is 80mg/m2, and the DLTs observation period is 1 cycle. If the patient cannot tolerate it, the dose will be reduced to 60mg/m2. In the second stage, advanced gastric cancer subjects who have progressed to first-line treatment will be included in two cohorts: those who have previously received immune checkpoint inhibitor therapy and have first-line PFS\&gt;7m (cohort 1) and those who have received standard systemic chemotherapy (cohort 2). 30 subjects will be included in each population, and a total of 66 subjects are planned to be enrolled. The study includes a screening period (from the signing of the informed consent form by the subjects to the first treatment, not exceeding 28 days), a treatment period (Adebrelimab combined with Apatinib and Lrinotecan liposome), and a follow-up period (including safety and survival follow-up).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age range: 18 to 75 years old, both male and female are acceptable;
•2. Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
•3. Patients who have only received one failed systemic treatment for advanced diseases in the past; After undergoing immunotherapy, the PFS of the treatment regimen containing immune checkpoint inhibitors must be greater than 7 months;
•4. According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);
•5. ECOG score: 0-1 point;
•6. Expected survival period ≥ 12 weeks;
•7. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula);
•8. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period, at least 6 months after the last use of Adebrelimab, at least 6 months after the last use of Apatinib, and at least 6 months after the last use of chemotherapy;
•9. HER2 negative;
•10. Voluntarily join this study, sign informed consent form, have good compliance, and cooperate with follow-up.

Exclusion Criteria

•1. History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
•2. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
•3. Have a history of allergies to any component of Adebrelimab in the past;
•4. Have received any of the following treatments:
•1. Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;
•2. Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;
•3. Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;
•4. Subjects who need to receive corticosteroids (equivalent to\>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Allow the use of hormones for routine chemotherapy pretreatment without the need for dose adjustment. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones;
•5. Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug;
•6. Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;
+10 more criteria

Locations (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science &amp;amp; Technology

Wuhan, Hubei, China

Key Dates

Start Date

September 30, 2024

Primary Completion Date

September 30, 2025

Completion Date

September 30, 2026

Last Updated

September 19, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Gastric Cancer

Interventions

Adebrelimab + Apatinib + Lrinotecan liposome

DRUG

Contacts

Xiang lin Yuan

CONTACT

+86 13986296106 yxl@medmail.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer

Inclusion Criteria

Exclusion Criteria

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