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Advanced Metastatic Gastric CancerPhase 2ASGARDNCT04089657

Apatinib Plus Sintilimab in Advanced Gastric Cancer Refractory to at Least Two Previous Chemotherapy Regimens

A Phase 2 study testing Apatinib Mesylate and Sintilimab in people with Advanced Metastatic Gastric Cancer, run by Fujian Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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 purpose of this study is to assess the efficacy and safety of Apatinib combined with PD-1 antibody Sintilimab for for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Advanced Metastatic Gastric Cancer
What is being tested?
Apatinib Mesylate and Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Dec 2019to 1 Dec 2021
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 20-75 years old
  • Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma
  • Life expectancy of more than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1
  • Have failed for at least 2 lines of chemotherapy
  • At least 3 weeks from previous chemotherapy at first dose of trial drug
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  • Resolution of all acute toxic side effects of prior therapy or surgical procedures to grade ≤ 1 National Cancer Institute-Common Toxicity Criteria (NCI-CTC) (except for the laboratory values)
  • Failure of prior palliative chemotherapy/chemotherapies (at least one irinotecan- or cisplatin-based). Failure is defined either by progression of disease or by significant toxicity that precludes further treatment.
  • At least one measurable lesion defined by RECIST 1.1 as determined by investigator assessment.
  • Has adequate organ function
  • At least 4 weeks from any major surgery (at first dose of trial drug)
  • Patients must be able to swallow apatinib

Who cannot join

  • In the past, participants have received anti PD-1, anti PD-L1 or anti PD-L2 drugs or drugs targeting another stimulation or synergistic inhibition of T cell receptors (such as Cytotoxic T-Lymphocyte Antigen 4 [CTLA-4] and CD137)
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix)
  • Less than 4 weeks from the last clinical trial
  • Active and uncontrollable bleeding from gastrointestinal tract
  • Known history of QT interval prolongation, ongoing QT prolongation (> 450 msec for males or > 470 msec for females), any cardiac ventricular dysrhythmias, atrial fibrillation of any grade
  • Hypertension that cannot be controlled by medications (> 140/90 mmHg despite optimal medical therapy)
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  • Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
  • Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  • Active uncontrolled infection
  • Known human immunodeficiency virus (HIV) infection
  • Symptomatic central nervous metastasis and/or cancerous meningitis
  • Known allergic/hypersensitivity reaction to any of the components of the treatment; or known drug abuse/alcohol abuse
  • Pregnant or lactating women

Trial locations and contacts

No sites are listed yet.

Nanfeng Fan, MD contact

008613705007267

Nanfeng_Fan@sina.com

JIE LIU, MD contact

008613860632919

dr2868@sina.com

About this study

Official title: Apatinib Plus Sintilimab in Patients With Advanced Gastric Cancer

The purpose of this study is to assess the efficacy and safety of Apatinib combined with PD-1 antibody Sintilimab for for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer

Read the detailed description

Patients with advanced gastric cancer (AGC) can be treated with multiple lines of chemotherapy. After second-line treatment some patients may receive third- and subsequent lines of chemotherapy if their performance status is well-preserved and they are willing to receive subsequent active treatments. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor approved by the CFDA for the treatment of advanced gastric cancer. In a phase III trial, apatinib significantly improved PFS and OS compared with placebo, but the clinical benefit was modest. As a result of toxicity, 850 mg/day Apatinib may cause dose reduction and delay in some patients ,which also caused some doubts. Therefore, it is a reasonable treatment strategy by reducing the dose and combining it with another low-toxic drug to achieve similar or better effects. Some studies have shown that the combination of targeted therapy and immunotherapy may be effective in solid tumor. Sintilimab (IBI308) is a monoclonal antibody targeting programmed death-1 (PD-1). So, the investigators designed an open-label, single-arm, phase II clinical study to evaluate the efficacy and safety of apatinib combined with Sintilimab in Chemotherapy-Refractory Advanced Metastatic Gastric Cancer.

Being tested
Apatinib Mesylate, Sintilimab

What participants receive

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

  • Apatinib MesylateDrug

    Also called Apatinib

    Apatinib 500mg qd, oral, taken half an hour after a meal

  • SintilimabDrug

    Also called IBI308

    Sintilimab 200mg intravenously on day 1

Study groups in NCT04089657
Study groupRoleWhat they receive
Apatinib+SintilimabExperimentalApatinib 500mg qd p.o and Sintilimab 200mg intravenously on day 1 every 3 weeks until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: Apatinib Mesylate; Drug: Sintilimab

What is being measured

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

  1. Disease control rate(DCR)

    The percentage of patients who have achieved complete response, partial response and stable disease,evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.

    Measured: 12 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    The percentage of patients who achieve complete response or partial response,evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.

    Measured: 12 months

  2. Overall survival (OS)

    Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.

    Measured: up to 12 months

  3. Duration of Response (DOR)

    Time from date of first RECIST response to progressive disease [PD] or death

    Measured: up to 12 months

  4. Progression Free Survival (PFS)

    PFS was calculated from the day of randomization to the date of first documented progression, or death from any cause.

    Measured: up to 12 months

  5. Adverse events（AE）

    Adverse events assessed using the NCI common toxicity criteria, version 4.01

    Measured: up to 12 months

Timeline

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

  1. First posted13 Sep 2019
  2. Study start1 Dec 2019 (estimated)
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion1 Dec 2021 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089657
Sponsor's protocol ID
APAICI
Acronym
ASGARD
Status last verified
Sep 2019
First submitted
10 Sep 2019
Last updated
13 Sep 2019
Results posted
No
Data monitoring committee
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 Mesylate and Sintilimab in people with Advanced Metastatic Gastric Cancer, run by Fujian Cancer 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 12 inclusion and 13 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 13 Sep 2019. 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?

Contact Nanfeng Fan, MD (008613705007267, Nanfeng_Fan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate(DCR) (time frame: 12 months). 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 NCT04089657.

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 13 Sep 2019.

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