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

Gastric Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05319639
• Other study ID #: SYLT-023
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Fujian Cancer Hospital
• Contact: lin rong bo, bachelor
• Phone: 13705919382
• Email: rongbo_lin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.

6. History of a stroke or CVA within 6 months.

7. Clinically significant peripheral vascular disease.

8. Inability to comply with study and/or follow-up procedures.

9. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.

Related Conditions & MeSH terms

• Gastric Cancer Stage IV
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin
Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
• Levo-Leucovorin
Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
• 5-fluorouracil
5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
• 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.
• 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.
• Tislelizumab
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Locations

Country	Name	City	State
China	Fujian cancer hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	Overall Response Rate	Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).	2 years
Secondary	Progression-free survival	The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).	2 years
Secondary	Overall survival	The length of time from enrollment until the time of death (OS, overall survival).	2 years