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Advanced Gastric CarcinomaPhase 2NCT04948125

Camrelizumab Combined With Apatinib for Advanced Gastric or Esophagogastric Adenocarcinoma

A Phase 2 study testing camrelizumab and Apatinib Mesylate in people with Advanced Gastric Carcinoma, run by Henan Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is a phase II study, to evaluate the effectiveness and safety of Camrelizumab combined with apatinib for advanced gastric or esophagogastric adenocarcinoma progressed after immune checkpoint inhibitors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Gastric Carcinoma
What is being tested?
camrelizumab and Apatinib Mesylate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
28 Apr 2021to 3 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient volunteered to participate in the study and signed an informed consent form；
  • ≥18 years old; male or female
  • confirmed incurable gastric and gastroesophageal junction adenocarcinoma（unresectable or metastatic) by pathological examination,at least have a measurable lesion without local treatment.(According to the RECIST V1.1,the long diameter of the lesion can be measured by spiral CT ≥10mm or the short diameter of the enlarged lymph nodes≥15mm;
  • Adequate standard treatment was used in the past; At least two cycles of anti-PD-1 / PD-L1 / CTLA-4 antibody therapy and platinum based chemotherapy were used in the past; Imaging confirmed disease progression occurred during or within 12 weeks after the treatment with anti-PD-1 / PD-L1 / CTLA-4 antibody；
  • It can provide the detection report of human epidermal growth factor receptor 2 (HER2); HER2 negative patients could be included in the study; HER2 positive patients who had failed to receive trastuzumab treatment in the past could be included in the study (HER2 positive was defined as ≥ 10% of tumor cells HER2 IHC 3 + or fish positive)；
  • Swallowing pills normally；
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  • ECOG score: 0~1 points;
  • Expected survival period ≥ 12 weeks; A histological specimen can be provided for secondary testing;
  • The main organ function meets the following criteria( It is not allowed to use any blood components or cell growth factor drugs within 14 days before the first medication）:
  • The absolute value of neutrophils (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) > 100 × 109 / L ；Albumin(ALB)≥ 90g / L;Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) ≤3 ULN; serum creatinine (Cr) ≤ 1.5 ULN ; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be included in the group);Alkaline phosphatase（AKP)≤ 2.5 times the upper limit of normal (ULN).
  • Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the end of the study; negative serum or urine pregnancy test within 72 hours prior to study enrollment and must be non-lactating patients; men should agree to patients who must use contraception during the study period and within 3 months after the end of the study period.

Who cannot join

  • Any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo or asthma in childhood had complete remission and did not need any intervention in adulthood were included; Asthma requiring medical intervention with bronchodilators could not be included;
  • Those who are using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones) and continue to use them within 2 weeks before entering the group;
  • Severe allergic reaction to other monoclonal antibodies;
  • Patients who end treatment due to related toxicity during anti-PD-1 / PD-L1 / CTLA-4 antibody treatment;
  • Patients with known central nervous system metastasis (except patients with stable disease control and asymptomatic after four weeks of radiotherapy or surgery) or evidence of cancerous meningitis;
  • Squamous or undifferentiated carcinoma of the stomach or gastroesophageal junction;
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  • The patients with ascites or pleural effusion with clinical symptoms who need puncture drainage or who have received pleural or ascites drainage within 2 weeks before randomization, except those who only showed a small amount of ascites or pleural effusion without clinical symptoms;
  • Other malignant tumors in the past 3 years or at the same time (except for cured basal cell carcinoma of skin and carcinoma in situ of cervix);
  • Patients with hypertension and cannot be well controlled after antihypertensive drug treatment (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg);
  • There are clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmias need treatment or intervention (5) QTc > 450ms (male); QTc > 470ms (female);
  • Low dose aspirin and low molecular weight heparin are allowed for prophylactic use in patients undergoing thrombolytic or anticoagulant therapy;
  • In the first 3 months of randomization, there were significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, hemorrhagic gastric ulcer or vasculitis; If the fecal occult blood is still positive at baseline (except for weak positive and no clinical significance judged by the researcher), gastroscopy should be performed (the researcher can judge whether gastroscopy should be performed for those who have undergone total gastrectomy before). If the gastroscopy results indicate severe gastric ulcer or the risk of bleeding judged by the researcher, they can not be enrolled; Gastrointestinal perforation or fistula occurred within 3 months before randomization;
  • The events of arteriovenous thrombosis occurred within 6 months before entering the group, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc;
  • Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, etc.)
  • Urine routine examination showed that urine protein was ≥ +, and 24-hour urine protein> 1.0 g；
  • Those who had received radiotherapy, chemotherapy, surgery (except diagnostic surgery) or trastuzumab for less than 4 weeks before randomization (palliative radiotherapy or local treatment can be extended to 2 weeks before randomization); Or the adverse reactions caused by previous treatment (except hair loss) did not return to ≤ CTCAE 5.0 1level ；
  • Patients with bone metastases received palliative radiotherapy in more than 5% bone marrow area within 2 weeks before the study；
  • Active infection, fever of unknown origin ≥ 38.5 ℃ within 7 days before medication, or white blood cell count > 15 at baseline × 109/L；
  • Congenital or acquired immune deficiency (such as HIV infection)；
  • Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA > 500 IU/ml); HCV reference: HCV antibody positive and HCV copy number > upper limit of normal value)；
  • Previous treatment with camrelizumab or apatinib;
  • Live vaccine may be vaccinated less than 4 weeks before or during the study;
  • According to the judgment of the researchers, the patients may have other factors that may affect the research results or lead to the termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors, which will affect the safety of the patients.

Trial locations and contacts

1 site in 1 country.

Ying Liu contact

13783604602

yaya7207@126.com

China1 site, 1 recruiting

  • Henan cancer hospital/The affiliated Cancer Hospital of ZhengZhou university

    Henan

    Ying L Liu

    Recruiting

Other trials in China

About this study

Official title: Camrelizumab Combined With Apatinib for Advanced Gastric or Esophagogastric Adenocarcinoma Progressed After Immune Checkpoint Inhibitors:a Single-arm,Open-label Prospective Trial

This study is a phase II study, to evaluate the effectiveness and safety of Camrelizumab combined with apatinib for advanced gastric or esophagogastric adenocarcinoma progressed after immune checkpoint inhibitors.

Being tested
camrelizumab, Apatinib Mesylate

What participants receive

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

  • camrelizumabDrug

    Also called SHR-1210

    200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.

  • Apatinib MesylateDrug

    250 mg qd

Study groups in NCT04948125
Study groupRoleWhat they receive
treatment groupExperimentalcamrelizumab combined with apatinib
Receives: Drug: camrelizumab; Drug: Apatinib Mesylate

What is being measured

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

  1. Objective response rate(ORR)

    ORR was defined as the percentage of participants with best overall response of either CR or PR

    Measured: up to 1 years

Secondary outcomes (5)

  1. Progression-Free Survival(PFS)

    PFS was defined as the time from the first day of treatment to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.

    Measured: up to 2 years

  2. Overall Survival (OS)

    OS was defined as the first day of treatment to death due to any cause.

    Measured: up to 2.5 years

  3. Disease control rate(DCR)

    DCR was defined as the percentage of participants with best overall response of either CR or PR or SD

    Measured: up to 1 years

  4. Time to progression(TTP)

    TTP was defined as the time from the first day of treatment to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants.

    Measured: up to 2years

  5. Duration of response(DOR)

    DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: up to 2years

Timeline

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

  1. First posted1 Jul 2021
  2. Study start28 Apr 2021
  3. Primary completion3 Jun 2022 (estimated)
  4. Study completion3 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
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04948125
Sponsor's protocol ID
MA-GC-Ⅱ-011
Status last verified
Jun 2021
First submitted
24 Jun 2021
Last updated
1 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing camrelizumab and Apatinib Mesylate in people with Advanced Gastric Carcinoma, run by Henan Cancer 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 11 inclusion and 23 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 1 Jul 2021. 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 Ying Liu (13783604602, yaya7207@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: up to 1 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 NCT04948125.

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 1 Jul 2021.

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