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Gastric Cancer Stage IVPhase 2NCT04267549

Conversion Therapy of Sintilimab in Combination With Apatinib and Chemotherapy in Stage IV Gastric Cancer

A Phase 2 study testing sintilimab, apatinib and S1 in people with Gastric Cancer Stage IV, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single-arm, phase II study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of apatinib and two-drug chemotherapy (S-1 plus nab-paclitaxel) as conversion therapy in patients with stage IV gastric cancer in China. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer Stage IV
What is being tested?
sintilimab, apatinib and S1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
1 May 2019to 30 Aug 2023
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • gastric adenocarcinoma confirmed by gastroscopy and pathology (histologically/cytologically ) ;
  • life expectancy of ≥3-month；
  • unresectable patients who were initially diagnosed as stage IV (clinical stage, American Joint Committee on Cancer 8th edition);
  • Eastern Cooperative Oncology Group performance status: 0-1;
  • must have at least 1 of the following unresectable factors indicated by CT, MRI or positron emission tomography(PET)-CT:
  • N3 lymphatic metastasis;
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  • Extensive or bulky lymph nodes;
  • T4b;
  • Hepatic metastasis: ≤5 lesions, total diameter of ≤8cm;
  • Peritoneal metastasis (CY1, P1);
  • Kukernburg tumor;
  • adequate organ function;
  • pregnant test negative of females of childbearing potential , and willing to use adequate contraception;
  • written Informed Consensus Form;

Who cannot join

  • prior use of any checkpoint inhibitor treatment, including PD-1, programmed cell death ligand-1(PDL-1), CTLA4 etc;
  • Her-2 positive with willing to use herceptin treatment;
  • prior active autoimmune disease or history of autoimmune disease;
  • clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) < 50%;
  • not controlled hypertension;
  • prior systemic treatment to metastatic disease；
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  • previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency;
  • history of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis ;
  • patients who may receive vaccination during study period;
  • mental disorders history, or psychotropic drug abuse history;
  • unable to orally administration;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Gastric Surgery, Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: Efficacy and Safety of Conversion Therapy With Sintilimab in Combination With Chemotherapy and Apatinib in Patients With Stage IV Gastric Cancer

This is a single-arm, phase II study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of apatinib and two-drug chemotherapy (S-1 plus nab-paclitaxel) as conversion therapy in patients with stage IV gastric cancer in China.

Keywords
PD-1 inhibitor, conversion therapy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • sintilimabDrug

    Also called Tyvyt

    a checkpoint inhibitor via blocking PD-1 (programmed cell death-1) site of signaling.

  • apatinibDrug

    a multi-target anti-angiogenic tyrosine kinase inhibitor (TKI)

  • S1Drug

    S-1 is an oral fluoropyrimidine consisting of tegafur (a prodrug that is converted to fluorouracil, mainly in liver microsomes but also in tumour tissue), gimeracil (an inhibitor of dihydropyrimidine dehydrogenase, which degrades 5-FU), and oteracil (which inhibits the phosphorylation of 5-FU in the gastrointestinal tract, thereby reducing the toxic effects of 5-FU in the intestinum).

  • Nab paclitaxelDrug

    Nab paclitaxel is a albumin-bound well tolerated paclitaxel than traditional paclitaxel

Study groups in NCT04267549
Study groupRoleWhat they receive
treatmentExperimentalEligible patients will be given sintilimab(200mg iv, day 1), apatinib(250mg,once daily), S-1 (60mg, twice daily, day1-14) and nab-paclitaxel(without peritoneal metastases: 260 mg/m^2 iv for 3h; with peritoneal metastases: 200mg/m^2 iv plus 60mg/m^2 ip; day 1) every 3 weeks for at least 3 cycles. The feasibility of surgery will be evaluated by a multidisciplinary team every 2-4 cycles. Patients assessed as inoperable will be allowed to continue maintenance therapy with the original regimen until disease progression or intolerable toxicity. For patients assessed as operable, apatinib will be discontinued and one more cycle of sintilimab combined with S-1 and nab-paclitaxel will be administered; radical surgery will be performed within 2-4 weeks after the end of treatment. Safety run-in stage will be set in the first 6 patients to determine the safety. The study will be terminated if dose-limiting toxicities (DLTs) occur in more than 2 patients.
Receives: Drug: sintilimab; Drug: apatinib; Drug: S1; Drug: Nab paclitaxel

What is being measured

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

  1. R0-surgery conversion rate

    The proportion of participants who underwent R0 surgery among all participants.

    Measured: up to one year

Secondary outcomes (7)

  1. objective response rate (ORR)

    The proportion of participants who achieved complete response(CR) or partial response(PR) per Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.1).

    Measured: up to one year

  2. disease control rate (DCR)

    The proportion of participants who achieved CR, PR or stable disease(SD) per RECIST v1.1.

    Measured: up to one year

  3. conversion rate

    The proportion of participants who underwent surgery among all participants.

    Measured: up to one year

  4. overall survival (OS)

    The time from the first dose of the study treatment to death from any cause.

    Measured: up to two years

  5. event-free survival (EFS)

    The time from the first dose of the study treatment to any of the following events: progression of disease, local or distant recurrence, or death due to any cause.

    Measured: up to two years

  6. Treatment-Related Adverse Events (TRAEs)

    The grade and proportion of participants who experienced TRAEs per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

    Measured: from the first day of treatment until 1 month after the end of treatment

  7. surgery-related complications

    Incidence and grade of surgery-related complications as assessed byper the Clavien-Dindo classification

    Measured: from the day of surgery to 30 days postoperatively

Timeline

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

  1. First posted13 Feb 2020
  2. Study start1 May 2019
  3. Primary completion1 Dec 2022
  4. Study completion30 Aug 2023 (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
Model description
eligible patients will be given treatment of sintilimab, apatinib and chemotherapy (nab-paclitaxel) every 3 weeks
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04267549
Sponsor's protocol ID
E20207
Status last verified
May 2023
First submitted
21 Jan 2020
Last updated
6 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sintilimab, apatinib and S1 in people with Gastric Cancer Stage IV, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

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 14 inclusion and 11 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

R0-surgery conversion rate (time frame: up to 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 NCT04267549.

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 6 Jul 2023.

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