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Recruiting NCT05319639

Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab

Phase I / Phase II Interventional Gastric Cancer Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxaliplatin, Levo-Leucovorin, 5-fluorouracil, Paclitaxel.
Who it may be relevant to
Registry conditions: Gastric Cancer Stage IV. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase I/II Study of the Combination of Irinotecan and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) and Tislelizumab

Overview

The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.

Interventions

  • Drug Oxaliplatin
    Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
  • Drug Levo-Leucovorin
    Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
  • Drug 5-fluorouracil
    5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
  • Drug Paclitaxel
    Paclitaxel will be administered on day 1 of each cycle at 45mg/m2 at dose level 1; 67.5 mg/m2 at dose level 2 ; 90 mg/m2 at dose level 3; 112.5 mg/m2 at dose level 4 once every 14 days.
  • Drug Irinotecan
    Irinotecan will be administered on day 1 of each cycle at 135 mg/m2 at dose level 1; 150 mg/m2 at dose level 2 once every 14 days.
  • Drug Tislelizumab
    Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Primary outcome measures

  • The maximum dose tolerated [Time frame: 1 month]
Secondary outcome measures (3)
  • Overall Response Rate [Time frame: 2 years]
  • Progression-free survival [Time frame: 2 years]
  • Overall survival [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
  • With or without measurable lesions.
  • Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • 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.
  • Life expectancy ≥3 months.
  • With normal electrocardiogram results and no history of congestive heart failure.
  • With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
  • 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
  • With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  • With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion criteria

  • 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.
  • Patients with brain or central nervous system metastases, including leptomeningeal disease.
  • Pregnant (positive pregnancy test) or breast feeding.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
  • History of a stroke or CVA within 6 months.
  • Clinically significant peripheral vascular disease.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian cancer hospital — Fuzhou

Identifiers

NCT: NCT05319639 · SYLT-023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗