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

ConditionGastric Cancer Stage IV
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Oxaliplatin

    Drug

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

  • Levo-Leucovorin

    Drug

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

  • 5-fluorouracil

    Drug

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

  • Paclitaxel

    Drug

    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.

  • Irinotecan

    Drug

    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.

  • Tislelizumab

    Drug

    Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Treatment groups

51 Participants
are divided into 1 treatment group
Group A: POFI and TislelizumabExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

The maximum dose tolerated

To determine the maximum tolerated dose of POFI with different doses of irinotecan and paclitaxel combined with Tislelizumab in the first month.

Time frame
1 month

Secondary outcomes

1

Overall Response Rate

Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).

Time frame
2 years
2

Progression-free survival

The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

Time frame
2 years
3

Overall survival

The length of time from enrollment until the time of death (OS, overall survival).

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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