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Advanced Pancreatic CancerPhase 2ASPCNCT03662035

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

A Phase 2 study testing Apatinib and S-1 in people with Advanced Pancreatic Cancer, run by Changzhou No.2 People's Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Apatinib and S-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
15 Sep 2018to 1 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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;
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  • 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;

About this study

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.

Read the detailed description
  1. 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].
  2. 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
Being tested
Apatinib, S-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    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.

  • S-1Drug

    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.

Study groups in NCT03662035
Study groupRoleWhat they receive
single-armExperimentalApatinib 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.
Receives: Drug: Apatinib; Drug: S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

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

    Measured: one year.

Secondary outcomes (4)

  1. Overall Survival

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

    Measured: one year.

  2. 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).

    Measured: one year.

  3. 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

    Measured: one year.

  4. 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

    Measured: one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start15 Sep 2018 (estimated)
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion1 Aug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662035
Sponsor's protocol ID
ChangzhouNo2
Acronym
ASPC
Status last verified
Sep 2018
First submitted
15 Aug 2018
Last updated
19 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib and S-1 in people with Advanced Pancreatic Cancer, run by Changzhou No.2 People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: one year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03662035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.

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