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

Study Overview

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

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

While AG (albumin-bound paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after AG regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received apatinib, irinotecan and S-1. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. The efficacy and safety data will be assessed through PFS, OS, ORR and adverse effects as graded by CTC-AE 5.0.

Metastatic Pancreatic Cancer

DRUG: Apatinib
DRUG: S-1 capsule
DRUG: Irinotecan

CSPAC-25

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-09-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-11-01
First Submitted that Met QC Criteria 2019-09-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-11-05
First Posted (ACTUAL) 2019-09-24	Results First Posted N/A	Last Verified 2019-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental: Apatinib + S-1+ Irinotecan Apatinib: 250mg po qd； 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; Irinotecan: According to the body surface area of 180 mg/m2, ivg	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 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 react

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental: Apatinib + S-1+ Irinotecan

Apatinib: 250mg po qd； 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; Irinotecan: According to the body surface area of 180 mg/m2, ivg

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

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 react

Primary Outcome Measures	Measure Description	Time Frame
Progression Free Survival	To investigate the progression-free survival (PFS) of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS)	through study completion, an average of 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival	To evaluate the overall survival of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS).	through study completion, an average of 1 year
Incidence of Adverse Events	Adverse events of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS).	through study completion, an average of 1 year
Overall Response Rate	To evaluate the overall response rate of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS)	through study completion, an average of 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xian-Jun Yu

Phone Number: +86 21 6417559

Email: yuxianjun@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Informed consent and willing to complete the study according to the protocol
ECOG performance scale ≤ 2;
Diagnosed as pancreatic adenocarcinoma by histology and cytology;
Treatment of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen
Baseline blood routine and biochemical indexes meet the following criteria:

The advanced pancreatic cancer pathology, with measurable lesions (spiral CT scan is more than 10 mm, according to the standard of RECIST 1.1);
Life expectancy ≥ 12 weeks;
Doctors believe that treatment can bring benefits to patients.

unwilling or unable to comply with the study protocol;
Other or malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
Allergy to apatinib, S-1 raw materials and/or their excipients;
Received VEGFR inhibitors, such as sorafenib, chougny for treatment;
Have high blood pressure and antihypertensive drug treatment can not drop to normal range(systolic pressure >140 mmHg, diastolic blood pressure 90>mmHg);
Suffering from coronary artery disease above grade I, grade I arrhythmia (including corrected QT interval prolongation male > 450 ms, women > 470 MS) and grade I heart insufficiency; urine protein positive patients.
Renal insufficiency, patients with previous kidney disease, urine protein positive (urinary protein detection 2+ or above, or 24-hour urine protein quantitation > 1.0g);
Has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.)
Pregnant or lactating women;
Coagulant function abnormality (INR>1.5、APTT>1.5 ULN) with bleeding tendency; Those with bleeding tendency (such as active ulcerative lesions in the stomach, fecal occult blood (++), vaginal and/or hematemesis within 3 months, hemoptysis) or lesions close to the large vessel site;
Patients with a deficiency of dihydropyrimidine dehydrogenase are known;
Evidence of any severe or uncontrolled systemic disease (eg, unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, high blood pressure, severe arrhythmia, diabetes, massive active bleeding);
Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
According to the investigator's judgment, there are other serious patients who are at risk to the patient's safety or affect the patient's accompanying disease.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Xian-Jun Yu, Fudan University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record