Phase II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab in Advanced Gastric Cancer

NCT ID: NCT06197438

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-04-01

Brief Summary

This study is a single center, phase II study, to evaluate the effectiveness and safety of PD-1 Antibody(Tislelizumab) Plus Irinotecan Combined With POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) , in the first-line treatment for patients with advanced/metastatic gastric cancer.

Detailed Description

This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to compare that ORR of patients with Tislelizumab plus Irinotecan and POF for advanced/metastatic gastric cancer.

In treatment period, patients will be administrated Tislelizumab plus Irinotecan and POF, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.

The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

POFI and Tislelizumab

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 21 days.

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.

Levo-Leucovorin

Intervention Type: DRUG

Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.

5-fluorouracil

Intervention Type: DRUG

5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.

Irinotecan Hydrochloride

Intervention Type: DRUG

Irinotecan will be administered on day 1 of each cycle at 135 mg/m2 once every 14 days.

Paclitaxel

Intervention Type: DRUG

Paclitaxel will be administered on day 1 of each cycle at 90 mg/m2 once every 14 days.

Interventions

Tislelizumab

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 21 days.

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.

Intervention Type: DRUG

Levo-Leucovorin

Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.

Intervention Type: DRUG

5-fluorouracil

5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.

Intervention Type: DRUG

Irinotecan Hydrochloride

Irinotecan will be administered on day 1 of each cycle at 135 mg/m2 once every 14 days.

Intervention Type: DRUG

Paclitaxel

Paclitaxel will be administered on day 1 of each cycle at 90 mg/m2 once every 14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.

2. With or without measurable lesions.

3. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

4. Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.

5. Life expectancy ≥3 months.

6. With normal electrocardiogram results and no history of congestive heart failure.

7. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.

8. Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug

9. With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.

10. With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria

1. Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.

2. Patients with brain or central nervous system metastases, including leptomeningeal disease.

3. Pregnant (positive pregnancy test) or breast feeding.

4. Serious, non-healing wound, ulcer, or bone fracture.

5. Significant cardiac disease as defined as: unstable angina, New York Heart 6.Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.

7.History of a stroke or CVA within 6 months. 8.Clinically significant peripheral vascular disease. 9.Inability to comply with study and/or follow-up procedures. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Rongbo Lin

Role: CONTACT

rongbo_lin@163.com

13705919382

Other Identifiers

SYLT-025

Identifier Type: -

Identifier Source: org_study_id