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

NCT04101929 | Unknown Phase 2

• 1 other identifier: CSPAC-25
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Metastatic Pancreatic Cancer

Keywords

metastatic pancreatic cancer; pancreatic adenocarcinoma; apatinib; S-1; irinotecan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival

  through study completion, an average of 1 year

• Incidence of Adverse Events

  through study completion, an average of 1 year

• Overall Response Rate

  through study completion, an average of 1 year

Study Arms (1)

Experimental: Apatinib + S-1+ Irinotecan

EXPERIMENTAL

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, ivgg/90min, once every two weeks.

Drug: Apatinib; Drug: S-1 capsule; Drug: Irinotecan

Interventions

Apatinib DRUG

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

Experimental: Apatinib + S-1+ Irinotecan

S-1 capsule DRUG

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.

Experimental: Apatinib + S-1+ Irinotecan

Irinotecan DRUG

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.

Experimental: Apatinib + S-1+ Irinotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Blood routine examination criteria must be met: (no blood transfusion within 14 days)
• HB≥90g/L；
• ANC≥1.5×109/L；
• PLT≥80×109/L
• Biochemical tests are subject to the following criteria:
• BIL \<1.25xULN ；
• ALT and AST\<2.5ULN；
• Serum creatinine. Less than 1 times the upper limit of normal value, Endogenous creatinine clearance\>50ml/min ( Cockcroft-Gault formula).
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

apatinib; S 1 (combination); Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Xian-Jun Yu

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Xian-Jun Yu

CONTACT

+86 21 6417559; yuxianjun@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 24, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)