Clinical trial · Interventional

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

PD-1 Antibody(Tislelizumab) Plus Irinotecan Combined With POF in Treatment Naive Advanced Gastric Cancer: A Phase II Study.

NCT06197438CI-TRIAL-00072828unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
5-fluorouracil	Drug	Fluorouracil	ALIAS
Irinotecan Hydrochloride	Drug	Irinotecan	ALIAS
Levo-Leucovorin	Drug	—	UNRESOLVED
Oxaliplatin	Drug	Oxaliplatin	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
Tislelizumab	Drug	Tislelizumab	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
POFI and Tislelizumab
interventionNames
1. Drug: Tislelizumab
2. Drug: Oxaliplatin
3. Drug: Levo-Leucovorin
4. Drug: 5-fluorouracil
5. Drug: Irinotecan Hydrochloride
6. Drug: Paclitaxel

Primary outcomes (1)

measure
Objective response rate(ORR)
timeFrame
From enrollment to 12 month
description
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.The ORR will be reported by percentage with each arms and appropriate confidence intervals.

Secondary outcomes (3)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.