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Apatinib, Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After AG Regimen

NCT04101929 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2019-11-05

No results posted yet for this study

Summary

This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of apatinib combined with irinotecan and S-1 (ApaIRIS) in treating Patients with metastatic pancreatic cancer after chemotherapy with albumin-bound paclitaxel plus gemcitabine regimen

Conditions

Interventions

DRUG

Apatinib

Patients receive Apatinib 250mg po qd , Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.

DRUG

S-1 capsule

Patients receive S-1 capsule According to the body surface area \<1.25m2 60mg/d, 1.25 \~ 1.5 m2 80 mg/d, \> 1.5m2 100mg/d po bid, taking 7 days, stopping for 7 days, 28 days for 1 cycle, Treatment repeats until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.

DRUG

Irinotecan

Patients receive Irinotecan According to the body surface area of 180 mg/m2, ivgg/90min, once every two weeks. Continuous chemotherapy until the criteria for discontinuation of the drug are met (eg, progression of the disease, intolerance of adverse reactions, or withdrawal of informed consent by the patient). Because the toxicity of apatinib or irinotecan or tigeol in the chemotherapy regimen meets the withdrawal criteria, the drug can be discontinued alone and the exact duration of the trial treatment recorded.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xian-Jun Yu · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04101929 on ClinicalTrials.gov