AzTrials
AzTrials

Gastric CancerPhase 2NCT04863430

Apatinib with Oxaliplatin and S-1 Treatment for Advanced Hepatoid Adenocarcinoma of the Stomach

A Phase 2 study testing Apatinib, Oxaliplatin and S1 in people with Gastric Cancer, run by Peking University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Gastric cancer is a highly heterogeneous tumor. The most commonly used clinical classifications of gastric cancer are Lauren classification (intestinal, diffuse, mixed) and World Health Organization(WHO) classification (papillary adenocarcinoma, tubular adenocarcinoma, mucinous glands cancer and low-adhesion cancer). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer
What is being tested?
Apatinib, Oxaliplatin and S1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
11 May 2021to 6 Jul 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 to 70 years old, no gender limitation;
  • Histopathological diagnosis of locally advanced, recurrent or metastatic HAS (pathological histomorphology and immunohistochemical diagnosis of AFP, sal-like 4(SALL4), Hep, glypican-3(GPC3), etc.);
  • Immunohistochemical(IHC) human epidermal growth factor receptor-2 (HER2) negative persons; HER2 positive is defined as IHC 3+ or IHC 2+ and fluorescence in situ hybridization(FISH)+, and FISH positive is defined as the ratio of HER2 gene copy number to chromosome 17 centromere(CEP17) signal number ≥2.0;
  • According to the RECIST 1.1 standard, at least one measurable lesion (spiral CT scan ≥10mm);
  • ECOG performance status(PS): 0-2 points;
  • The expected survival time is ≥3 months;
Show all 21Show fewer
  • The main organs are functionally normal, without serious blood, heart, lung, liver, kidney dysfunction and immune deficiency disease. The blood test meets the following requirements; (1) Routine blood examination, which must be met (no blood transfusion within 14 days);
  • HGB≥100g/L;
  • WBC≥4.0×10^9/L; absolute neutrophil count(ANC) ≥2.0×10^9/L;
  • PLT≥2.0×10^9/L; (2) The biochemical inspection must meet the following standards:
  • <!-- -->
  • BIL≤1.5 times the upper limit of normal (ULN);
  • Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN;
  • serum Cr≤1.5×ULN, endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula); (3) Occult blood in stool (-); (4) Urine routine is normal, or urine protein <(++), or 24-hour urine protein <1.0g;
  • The coagulation function is normal, without active bleeding and thrombosis disease;
  • International standardized ratio INR≤1.5×ULN;
  • Partial thromboplastin time APTT≤1.5×ULN;
  • Prothrombin time PT≤1.5×ULN;
  • Female subjects with fertility and male subjects whose partner is a female of childbearing age who need to take effective contraceptive measures during the study treatment period and at least 6 months after the last use of the study drug;
  • Subjects voluntarily participate in this study and sign an informed consent form (ICF);
  • Those who have good compliance and can follow up as required by the plan.

Who cannot join

  • Various types of liver inflammatory diseases (especially hepatitis A, B, and C viral hepatitis active period) and other diseases that may produce AFP such as liver cirrhosis;
  • Germ cell tumors;
  • Have previously received any regimen of palliative chemotherapy for gastric cancer;
  • Have previously received apatinib treatment;
  • S-1 and/or oxaliplatin have been used in the past 6 months;
  • Those who have hypertension and cannot be reduced to the normal range after treatment with antihypertensive drugs (shrinking Pressure>140mmHg or diastolic pressure>90mmHg);
Show all 16Show fewer
  • Suffering from coronary heart disease ≥2 grade, arrhythmia corrected QT interval(QTc) interval prolonged male> 450ms, female;>470ms) and cardiac insufficiency;
  • There are many factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic abdominal Diarrhea and intestinal obstruction, etc.);
  • Patients at risk of gastrointestinal bleeding or those with a history of gastrointestinal bleeding within 1 month;
  • Abnormal blood coagulation function (INR>1.5×ULN, activated partial thromboplastin time(APTT)>1.5×ULN), those with bleeding tendency;
  • Those with thrombotic diseases or receiving anticoagulant treatment;
  • Those with peripheral sensitive neuropathy with dysfunction;
  • Central nervous system metastasis;
  • Pregnant or lactating women;
  • Those who have participated in other clinical research in the past 30 days;
  • Other patients considered by the treating physician to be unsuitable for inclusion

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital / Peking University Cancer Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Gastric cancer is a highly heterogeneous tumor. The most commonly used clinical classifications of gastric cancer are Lauren classification (intestinal, diffuse, mixed) and World Health Organization(WHO) classification (papillary adenocarcinoma, tubular adenocarcinoma, mucinous glands cancer and low-adhesion cancer). Hepatoid adenocarcinoma of the stomach (HAS) is a special and rare type of gastric cancer.

Compared with ordinary gastric cancer, HAS has unique clinicopathological characteristics, prone to liver metastasis and lymph node metastasis, has a highly aggressive and malignant biological behavior, a worse prognosis than alpha fetoprotein(AFP) normal gastric cancer, and is easily confused with hepatocellular carcinoma(HCC). There is the possibility of misdiagnosis and mistreatment, so it has gradually attracted people's attention. Most of the domestic and foreign literature on HAS in the past 30 years are retrospective cases or small sample reports, and there are few prospective studies. There is no standard treatment plan for HAS. The main treatment is based on gastric adenocarcinoma. The clinical treatment principle is a comprehensive treatment plan with surgical resection as the mainstay, supplemented by systemic chemotherapy and local interventional therapy. This type of gastric cancer has a relatively high degree of malignancy, rapid progress of the disease, and easy recurrence after surgery. There is no standard treatment plan in China and other foreign countries.

The aim of this study was to evaluate the efficacy and safety of apatinib with oxaliplatin and S-1 treatment advanced hepatoid adenocarcinoma of the stomach.

Conditions
Gastric Cancer
Being tested
Apatinib, Oxaliplatin, S1
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • ApatinibDrug

    Also called Apatinib Mesylate Tablets

    500mg oral qd

  • OxaliplatinDrug

    Also called Oxaliplatin for Injection

    130mg/m^2 administered as IV infusion on Days 1 of each 21-day cycle

  • S1Drug

    Also called Tegafur Gimeracil Oteracil Potassium Capsule

    According to body surface area,(<1.5m^2) 40mg or (≥1.5m^2)50mg bid oral on Day 1-14 of each 21-day cycle

Study groups in NCT04863430
Study groupRoleWhat they receive
Apatinib with chemotherapyExperimentalApatinib with oxaliplatin and S-1 treatment
Receives: Drug: Apatinib; Drug: Oxaliplatin; Drug: S1

What is being measured

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

  1. Objective Response Rate（ORR）

    The percentage of patients having a complete response(CR) or a partial response(PR) to protocol treatment. Objective response will be measured by RECIST 1.1.

    Measured: Estimate up to 2 years.

Secondary outcomes (4)

  1. Overall Survival (OS)

    The length of time from enrollment until the time of death.

    Measured: Estimate up to 5 years.

  2. Progression-free Survival (PFS)

    The time from enrollment to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.

    Measured: Estimate up to 2 years.

  3. Disease Control Rate (DCR)

    The percentage of the participants in the analysis population who had a confirmed CR or PR or stable disease(SD) according to RECIST 1.1 based on investigator assessment.

    Measured: Estimate up to 2 years.

  4. Adverse events

    The incidence of adverse events and the incidence of severe adverse events

    Measured: Estimate up to 2 years.

Timeline

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

  1. First posted28 Apr 2021
  2. Study start11 May 2021
  3. Primary completion6 Jul 2023
  4. Study completion6 Jul 2023

Why it stopped: The anti-PD-1 agents were proved effective by several clinical trials and recommended to treat gastric cancer. In order to protect the interest of patients, this trial was withdrawn after carefully discussion with all investigators.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04863430
Sponsor's protocol ID
GC01
Status last verified
Feb 2025
First submitted
26 Apr 2021
Last updated
21 Feb 2025
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, Oxaliplatin and S1 in people with Gastric Cancer, run by Peking University 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 21 inclusion and 16 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: withdrawn, as of the sponsor's last update on 21 Feb 2025. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Objective Response Rate（ORR） (time frame: Estimate up to 2 years.). 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 NCT04863430.

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 21 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in