Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer

NCT03662035 | Unknown Phase 2

• 1 other identifier: ChangzhouNo2
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to determine the efficacy and safety of apatinib combined with S-1 on advanced pancreatic cancer patients after failure of first-line chemotherapy.

Conditions

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression-free survival is defined as the time from registration to the earlier of death or disease progression.

  one year.

Secondary Outcomes (4)

• Overall Survival

  one year.

• Duration of response

  one year.

• Objective response rate

  one year.

• Disease Control Rate

  one year.

Study Arms (1)

single-arm

EXPERIMENTAL

Apatinib and S-1 Patients will be offered with Apatinib (500mg/d) and S-1 (60mg/d for BSA\<1.25m2, 80mg/d for 1.25\<BSA\<1.5m2, and 100mg for BSA \>1.5m2) until their disease have progressed.

Drug: Apatinib; Drug: S-1

Interventions

Apatinib DRUG

Apatinib Patients with advanced pancreatic cancer after failure of first-line chemotherapy will receive Apatinib (500mg/d, orally) 30 minutes after meal with warm water.Take 21 days as a cycle, patients will receive this treatment until they have got disease progressed. Dose adjustment: with 3/4 level of adverse reactions, the dose should be lowered to 250 mg/d.

single-arm

S-1 DRUG

S-1 Patients will receive S-1 (60mg/d for BSA\<1.25m2, 80mg/d for 1.25\<BSA\<1.5m2, and 100mg for BSA \>1.5m2, orally) twice a day, once after breakfast and once after dinner, for 14 days, 7 days for suspension and 21 days as one cycle.

single-arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• ECOG score: 0-2;
• Have confirmed metastatic or locally advanced unresectable pancreatic cancer;
• At least one measurable lesion according to the RECIST1.1 standard;
• First-line chemotherapy drugs do not include S-1 or fluorouracil drugs;
• Main organ functions meet the following standards:
• Baseline blood routine (the inspection standard should meet the requirements of no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulant correction) :
• Hemoglobin\>80g/L
• The absolute neutrophil count (ANC) 1.5 x 109 / L;
• Blood platelet (PLT)\> 90 x 109 / L;
• Baseline biochemical test shall meet the following standards:
• T BIL \< 1.5\*ULN.
• A LT and AST\<2.5\*ULN, and in patients with liver metastasis \< 5\*ULN;
• Cr≤1.5\*ULN.
• Albumin is greater than or equal to 30g/L;

You may not qualify if:

• Clearly allergic to apatinib, S-1 or their excipients;
• There are various factors affecting oral drugs (including dysphagia, chronic diarrhea, intestinal obstruction, etc.);
• Serious heart diseases in the last six months, including :
• angina;
• myocardial infarction;
• heart failure;
• interphase of QTc \>450ms;
• any other heart diseases that were judged as unsuitable for the study;
• Combined with uncontrollable hypertension after drug treatment (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg);
• Complicated with other serious medical diseases, including cerebrovascular disease, uncontrolled infection, active peptic ulcer, intestinal obstruction, etc.;
• Metastasis of tumor central nervous system;
• Women during pregnancy and lactation;
• The patient has been diagnosed with other tumors in the past five years, except for the following situations: B. Cured basal cell carcinoma of the skin and cured orthotopic carcinoma of the cervix;
• The time from the last chemotherapy is shorter than 4 weeks or 5 half-life (the time taken is older), and the time from the last radiotherapy is shorter than 4 weeks;
• Use the experimental drug within 28 days before enrollment;

Sponsors & Collaborators

• Changzhou No.2 People's Hospital: lead

MeSH Terms

Interventions

apatinib; S 1 (combination)

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: Director, head of oncology department, principal investigator, clinical professor

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: September 7, 2018
• Study Start: September 15, 2018
• Primary Completion: March 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share