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AzTrials

Gastric CancerPhase 2NCT05184946

Clinical Study of Camrelizumab Combined With SOX in the Adjuvant Treatment of Advanced Gastric Adenocarcinoma or Gastric Esophageal Junction Adenocarcinoma

A Phase 2 study testing Camrelizumab Combined with SOX in people with Gastric Cancer, run by The Second Affiliated Hospital of Shandong First Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study the efficacy and safety of camrelizumab combined with SOX regimen for adjuvant therapy of stage III gastric cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
Camrelizumab Combined with SOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
9 Oct 2021to 8 Oct 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

  • Age 18-75y, male or female; 2. Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histology or cytology; 3. Patients with stage III gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received any antitumor therapy besides surgery; 4. ECOG score: 0 ~ 1; 5. Expected survival ≥12 weeks; 6. The main organs function are well, and the laboratory test data meets the following standards: (1) Blood routine: neutrophil absolute count ≥1.5×109/L (or greater than the lower limit of laboratory normal value in the research center), platelet count ≥100×109/L, hemoglobin ≥90g/L; (2) Liver function: serum total bilirubin ≤1.5 times the upper limit of standard value (ULN), AST and ALT≤2.5 times ULN, and ≤5 times ULN if liver metastasis exists; (3) Renal function: CrCl≥ 60mL /min/1.73m2 (calculated according to the Cockcroft-Gault formula); 7. Female subjects with the fertility, as well as the partner of male subjects with the fertility, need to use an approved medical contraception (such as intrauterine device, the pill or condoms) during the research and at least 6 months from the last treatment of camrelizumab or chemotherapy; 8. HER2 negative, volunteering to provide tumor tissue samples after surgery and adjuvant therapy; 9. Voluntarily participated in the study and signed informed consent with good compliance and follow-up.

Who cannot join

  • History of gastrointestinal perforation and/or fistula within 6 months prior to first medication; 2. Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion requiring repeated drainage; 3. Allergic to carrelizumab, oxaliplatin, or tegio; 4. Received any of the following treatments: a. Enrolled in another clinical study at the same time; b. Prior to initial use of the study drug, antitumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy, or tumor embolization, etc.) was performed; c. Subjects requiring corticosteroids (> 10mg prednisone equivalent daily dose) within 2 weeks prior to initial use of the study drug. Other special situations require communication with the researcher. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at doses > 10mg/d of prednisone efficacy are permitted; d. Those who have received antitumor vaccine or have received live vaccine within 4 weeks prior to the first administration of the study drug; e. Major surgery or severe trauma within 4 weeks prior to first use of the study drug; 5. Patients with central nervous system metastasis; 6. Have active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Except for patients with epilepsy or recovered childhood asthma/allergy without any intervention as adults; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type 1 diabetes with a steady dose of insulin; 7. Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis b: HBV-dna test value over 500IU/ml or 2500 copies /ml); 8. The subject has cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: e.g. : (1) NYHA class II or higher heart failure; (2) unstable angina; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are still poorly controlled without or after clinical intervention; 9. Severe infection (CTCAE5.0 > 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging suggests active lung inflammation, signs and symptoms of infection within 2 weeks prior to initial use of the study drug, or the need for oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics; 10. A history of interstitial lung disease (excluding radiation pneumonia or non-infectious pneumonia without hormone therapy); 11. Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year before enrollment, or patients with active tuberculosis infection history more than 1 year ago but without formal treatment;12. Diagnosis of any other malignancy, other than malignancies with a low risk of metastasis and death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix, within 5 years prior to first use of the study drug; 13. Pregnant or lactating women; 14. In the judgment of the investigator, the subject has other factors that may cause him/her to be forced to terminate the study, such as other serious diseases (including mental illness) requiring combined treatment, seriously abnormal laboratory test values, family or social factors that may affect the safety of the subject or the collection of test data; 15. According to the investigator's judgment, subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental illness) requiring combined treatment, seriously abnormal laboratory test values, family or social factors that may affect subjects' safety or the collection of test data.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an, Shandong, 271000

    Zhensheng Fang, +86-0538-6236830, liweiweicool@163.com

    Haiyan Liu

    Recruiting

Other trials in China

About this study

To study the efficacy and safety of camrelizumab combined with SOX regimen for adjuvant therapy of stage III gastric cancer

Read the detailed description

The purpose of this study is to explore the efficacy of anti-PD1 therapy combined with SOX for adjuvant therapy of advanced gastric cancer compared to the standard SOX regimen. Besides the efficacy, we focus on the safety and quality of life in the new treatments.

Conditions
Gastric Cancer
Being tested
Camrelizumab Combined with SOX
Keywords
advanced gastric cancer, camrelizumab, adjuvant treatment
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Camrelizumab Combined with SOXDrug

    Also called Anti-PD1 Combine with chemotherapy

    Administer camrelizumab and SOX regimen in the adjuvant treatment of advanced gastric adenocarcinoma or gastric esophageal junction adenocarcinoma

Study groups in NCT05184946
Study groupRoleWhat they receive
Anti-PD1 combined with SOXExperimentalCamrelizumab will be administered one day before SOX regimen.
Receives: Drug: Camrelizumab Combined with SOX

What is being measured

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

  1. 3 years disease free survival rate

    With 3 years of follow-up,the three-year disease-free survival rate will be observed and compared with the target value.

    Measured: 3 years

Secondary outcomes (1)
  1. overall survival time

    With 2 and 3 years of follow-up,the 2/3-year overall survival time will be observed and compared with the target value.

    Measured: 2 years, 3 years

Timeline

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

  1. First posted11 Jan 2022
  2. Study start9 Oct 2021
  3. Primary completion8 Oct 2025 (estimated)
  4. Study completion8 Oct 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
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05184946
Sponsor's protocol ID
MT-002
Status last verified
Dec 2021
First submitted
22 Dec 2021
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.

    PubMed 34102137
  • Hermann RM, Christiansen H. [A new standard is emerging: PD-1 maintenance therapy after neoadjuvant radiochemotherapy and curative resection of oesophageal and AEG carcinomas (CheckMate 577)]. Strahlenther Onkol. 2021 Nov;197(11):1040-1042. doi: 10.1007/s00066-021-01849-3. Epub 2021 Sep 13. No abstract available. German.

    PubMed 34515819

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab Combined with SOX in people with Gastric Cancer, run by The Second Affiliated Hospital of Shandong First Medical 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 1 inclusion and 1 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 Jan 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 Qijun Yi (+86-18265384981, yiqijun1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3 years disease free survival rate (time frame: 3 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 NCT05184946, which also lists 2 linked publications.

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 Jan 2022.

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