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Gastric CancerPhase 2NCT05216237

A Study to Evaluate the Efficacy and Safety of Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative Microsatellite Stability (MSS) Advanced or Metastatic Gastric (GC) or Gastroesophageal Junction (GEJ) Cancer

A Phase 2 study testing Sintilimab 200 mg, intravenously (IV) every 3 weeks(Q3W) in people with Gastric Cancer and Chemotherapy, run by Jiuda Zhao 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the efficacy and safety of Sintilimab combined with apatinib and chemotherapy as First-line or second-line Therapy in Treatment of HER-2 negative MSS Advanced or Metastatic GC or GEJ Cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer, Chemotherapy, Immunotherapy
What is being tested?
Sintilimab 200 mg, intravenously (IV) every 3 weeks(Q3W)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
15 Feb 2022to 1 Jun 2025
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

  • Patients with inoperable advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma confirmed by histology, and HER-2 negative by immunohistochemistry. HER-2 negative was defined as immunohistochemistry 0-1 + or 2 + but fish results were negative.
  • According to recist1 1 measurement standard at least one or more target lesions can be measured.
  • Patients with microsatellite stability (MSS type) or normal mismatch repair protein (PMMR) confirmed by immunohistochemistry or second-generation sequencing..
  • Aged 18-75.
  • The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1 points.
  • Life expectancy is more than 3 months.
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  • The blood routine examination was basically normal within 1 week before enrollment (taking the normal value in the laboratory of each research center as the standard). The white blood cell count (WBC) ≥ 2.5 × 10^9 / L or neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 100 × 10^9/L； Hemoglobin ≥ 9.0 g / dl. Patients can receive blood transfusion or erythropoietin treatment to meet this standard.
  • The liver and kidney function, nail function and coagulation function were basically normal within 1 week before enrollment (based on the normal values in the laboratories of each research center). Total bilirubin (TBIL) ≤ 1.5 × Upper limit of normal value (ULN); alanine aminotransferase (SGPT / ALT) ≤ 2.5 × ULN (patients with liver metastasis) ≤ 5 × ULN);Aspartate aminotransferase (SGOT / AST) ≤ 2.5 × ULN (patients with liver metastasis) ≤ 5 × ULN);Creatinine clearance rate (CCR) ≥ 60 ml / min; Urinary protein < 2 +; If urinary protein ≥ 2 +, 24-hour urinary protein must be ≤ 1g; Thyroid stimulating hormone (TSH) ≤ upper limit of normal value (ULN); in case of abnormality, T3 and T4 levels shall be measured; if T3 and T4 levels are normal, they can be selected. International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN。
  • The patient is willing and able to comply with the provisions of the study protocol during the study.
  • Before entering the study, during the study and within 6 months after the end of treatment, patients with fertility must take effective contraceptive measures (hormone or barrier contraception; abstinence).
  • The subject agreed not to participate in another intervention study when receiving the study drug in this study. Subjects ended the last study for more than 1 month.
  • Subjects who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy or chemoradiotherapy) of GC / GEJ must complete the last dose of treatment at least 6 months before the first study treatment. Palliative radiotherapy is allowed, but it must be completed 2 weeks before the start of study treatment.

Who cannot join

  • Patients who have received chemotherapy, radiotherapy or biological therapy within two weeks. Received any investigational drug within 4 weeks before the start of study treatment.
  • Pregnant or lactating women; women with fertility have a positive pregnancy test or no pregnancy test at the time of screening.
  • Severe / uncontrolled intermittent disease / infection.
  • Obvious cardiovascular disease (history of congestive heart failure > NYHA class II, unstable angina pectoris or myocardial infarction, unstable angina pectoris or myocardial infarction, or severe arrhythmia in the past six months).
  • History or evidence of hereditary bleeding syndrome or coagulation disease with bleeding risk, history of thrombotic disease and active gastrointestinal bleeding.
  • There have been arterial thromboembolism events in the past 6 months, including transient ischemic attack and cerebrovascular accident.
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  • Patients with previous malignant tumors, unless the previous malignant tumors have been diagnosed and treated for more than 5 years, and there is no evidence of recurrence.
  • The subjects have known human immunodeficiency virus (HIV) infection or known positive detection history of active hepatitis B (positive HBsAg) or hepatitis C infection. The subjects with HBsAg negative but HBC AB positive will be tested for HBV DNA replication. If it is greater than the minimum copy number of HBV DNA, the subjects will be excluded. The subjects with seropositive but hepatitis C virus The subjects with negative replication results of (HCV) RNA test are eligible for inclusion.
  • Patients with neuropathy > grade 3 at screening.
  • Patients with QTc > 500msec during screening.
  • Patients with meningeal disease and no other measurable brain metastasis were excluded.
  • Have received bevacizumab, sorafenib, sunitinib or other VEGF pathway targeted therapy.
  • Have a history of severe hemoptysis.
  • Having a mental illness or social situation can hinder study compliance.
  • A severe nonunion wound, ulcer, or bone fracture.
  • Major surgery, open biopsy or major trauma within 28 days before enrollment, and minor surgery within 7 days before enrollment.
  • Have a history of allergic reaction to compounds similar to the chemical composition of the study drug.
  • Take chronic daily aspirin (> 325 mg / day), dipyridamole, ticlopidine, clopidogrel, cilostazol, non steroidal anti-inflammatory drugs and other drugs known to inhibit platelet function.
  • Recent formal antihypertensive treatment still failed to control hypertension (systolic blood pressure greater than 140mmHg and diastolic blood pressure greater than 90mmHg), and the patients had obvious symptoms of hypertension.

Trial locations and contacts

1 site in 1 country.

Zhao Jiuda, MD contact

+86 13327661976

jiudazhao@126.com

China1 site, 1 recruiting

  • Affiliated Hospital of Qinghai University

    Xining, Qinghai, 810000

    Zhao Jiuda, +86 13327661976, jiudazhao@126.com

    Recruiting

Other trials in China

About this study

Official title: An Open-Label, Multi-Center, Phase II Study to Evaluate the Efficacy and Safety of PD-1 Antibody Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative MSS Advanced or Metastatic GC or GEJ Cancer

To evaluate the efficacy and safety of Sintilimab combined with apatinib and chemotherapy as First-line or second-line Therapy in Treatment of HER-2 negative MSS Advanced or Metastatic GC or GEJ Cancer. At the same time, the correlation between tissue programmed death ligand-1(PD-L1) expression and blood circulating tumor cell(CTC) counts and the efficacy of immune combination therapy was also explored.

Read the detailed description

Participants receive Sintilizumab 200 mg, intravenously (IV) every 3 weeks(Q3W);plus Apatinib 250 mg twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days; plus Tegafur gimeracil oteracil potassium capsules (40mg for body surface area < 1.25/m^2, 50mg/m^2 for body surface area 1.25-1.5m^2, 60mg for body surface area > 1.5/m^2) BID by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus Oxaliplatin 85 mg/m^2, IV Q3W; for 4-6 cycles followed by Cindilizumab plus Tegafur gimeracil oteracil potassium capsules.

Being tested
Sintilimab 200 mg, intravenously (IV) every 3 weeks(Q3W)
Keywords
Gastric Cancer, Chemotherapy, Immunotherapy, Microsatellite stability
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Sintilimab 200 mg, intravenously (IV) every 3 weeks(Q3W)Drug

    Also called Apatinib 250 mg twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days;, Tegafur gimeracil oteracil potassium capsules twice daily (BID) by continous oral adminstration for 14 days, every 3 weeks(Q3W), Oxaliplatin 85 mg/m^2, IV every 3 weeks(Q3W)

    for 2-6 cycles followed by Sindilizumab plus Tegafur gimeracil oteracil potassium capsules.

Study groups in NCT05216237
Study groupRoleWhat they receive
Treatment of HER-2 Negative MSS Advanced GastricExperimentalSintilimab Plus Apatinib and Chemotherapy in Patients with Previously Untreated HER-2 negative MSS Advanced or Metastatic GC or GEJ Cancer
Receives: Drug: Sintilimab 200 mg, intravenously (IV) every 3 weeks(Q3W)

What is being measured

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

  1. Objective Response Rate (ORR)

    per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: 36 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    per RECIST 1.1

    Measured: 36 months

  2. Disease Control Rate (DCR)

    per RECIST 1.1

    Measured: 36 months

  3. Duration of Response (DoR)

    per RECIST 1.1

    Measured: 36 months

  4. Adverse events (AEs)

    Number of Subjects with treatment-related adverse events

    Measured: 36 months

Timeline

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

  1. First posted31 Jan 2022
  2. Study start15 Feb 2022
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2025 (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
Patients who meet the inclusion criteria will receive with sintilimab combined with apatinib and chemotherapy(Oxaliplatin plus Tegafur gimeracil oteracil potassium capsules). At the same time, tumor samples were collected for tissue PD-L1 detection and blood samples for CTC detection according to the wishes of patients. Patients underwent contrast-enhanced thoracoabdominal and pelvic Computer Tomography(CT) at baseline and every 6 weeks after enrollment. Patients with stable or remission after 2 to 6 cycles of combined treatment can reduce the evaluation frequency to once every 12 weeks during the maintenance treatment period.
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216237
Sponsor's protocol ID
AHQU-2022001
Status last verified
Apr 2022
First submitted
19 Jan 2022
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab 200 mg, intravenously (IV) every 3 weeks(Q3W) in people with Gastric Cancer and Chemotherapy, run by Jiuda Zhao 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 12 inclusion and 19 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 11 Apr 2022. 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?

Contact Zhao Jiuda, MD (+86 13327661976, jiudazhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 36 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 NCT05216237.

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 11 Apr 2022.

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