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

Primary Purpose

Advanced Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Apatinib

S-1

About this trial

This is an interventional treatment trial for Advanced Pancreatic Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

18-70 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;
Women of child-bearing age must already have access to reliable contraception. Pregnancy tests (serum or urine) were performed within 7 days prior to enrollment and the results were negative, and a reliable method of contraception was preferred 8 weeks after the trial period and the last drug administration;
Subjects will voluntarily join the study and sign the informed consent.

Exclusion criteria:

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;
Patients with grade 2 or above toxicity caused by the use of anti-tumor drugs before enrollment;
Have mental disorders or a history of substance abuse;
Other circumstances that the investigator deems inappropriate to participate in the study;

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression Free Survival

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

Secondary Outcome Measures

Overall Survival

OS refers to the date of registration to the date of death for any cause.

Duration of response

DOR refers to the time from the time the measurement first conforms to the CR or PR criteria (whichever is first measured) to the time the first true record of disease recurrence or progression (using the minimum measurements recorded in the trial as a reference for disease progression).

Objective response rate

ORR refers to the proportion of patients whose tumors have shrunk to a certain extent for a certain period of time, including CR and PR cases

Disease Control Rate

DCR refers to the percentage of patients with confirmed complete remission, partial remission, and disease stabilization (> 8 weeks) who can evaluate efficacy

Full Information

NCT ID

NCT03662035

First Posted

August 15, 2018

Last Updated

September 18, 2018

Sponsor

Changzhou No.2 People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03662035

Brief Title

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

Acronym

ASPC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2018 (Anticipated)

Primary Completion Date

March 1, 2020 (Anticipated)

Study Completion Date

August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changzhou No.2 People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

Detailed Description

To observe the curative efficacy of apatinib and S-1 on patients by analyzing the data of overall survival (OS), complete remission (CR) or partial remission (PR), the rate of progression free survival (PFS), levels of CA19-9 and VEGFR in serum [Time Frame: Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year]. To observe any adverse events, including abnormal clinical symptoms and vital signs, abnormal laboratory examinations, and to record the clinical features, severity, occurrence time, duration, management and prognosis of all subjects during the clinical study, and to determine the correlation between these adverse events and the experimental drugs. . The safety of drugs used in advanced pancreatic cancer was evaluated by CTCAE v4.0

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single-arm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

S-1

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

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

Time Frame

one year.

Secondary Outcome Measure Information:

Title

Overall Survival

Description

OS refers to the date of registration to the date of death for any cause.

Time Frame

one year.

Title

Duration of response

Description

Time Frame

one year.

Title

Objective response rate

Description

ORR refers to the proportion of patients whose tumors have shrunk to a certain extent for a certain period of time, including CR and PR cases

Time Frame

one year.

Title

Disease Control Rate

Description

DCR refers to the percentage of patients with confirmed complete remission, partial remission, and disease stabilization (> 8 weeks) who can evaluate efficacy

Time Frame

one year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 18-70 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; Women of child-bearing age must already have access to reliable contraception. Pregnancy tests (serum or urine) were performed within 7 days prior to enrollment and the results were negative, and a reliable method of contraception was preferred 8 weeks after the trial period and the last drug administration; Subjects will voluntarily join the study and sign the informed consent. Exclusion criteria: 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; Patients with grade 2 or above toxicity caused by the use of anti-tumor drugs before enrollment; Have mental disorders or a history of substance abuse; Other circumstances that the investigator deems inappropriate to participate in the study;

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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