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.
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
- Recruiting
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000
Zhensheng Fang, +86-0538-6236830, liweiweicool@163.com
Haiyan Liu
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 group | Role | What they receive |
|---|---|---|
| Anti-PD1 combined with SOX | Experimental | Camrelizumab 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.
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)
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.
- First posted11 Jan 2022
- Study start9 Oct 2021
- Primary completion8 Oct 2025 (estimated)
- Study completion8 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haiyan liu, Principal investigator, The Second Affiliated Hospital of Shandong First Medical University
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 34102137Hermann 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Camrelizumab Combined With SOX in the Adjuvant Treatment of Advanced Gastric Adenocarcinoma or Gastric Esophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05184946
- Acronym / sponsor ID
- MT-002
- Conditions
- Gastric Cancer
- Keywords
- advanced gastric cancer, camrelizumab, adjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical UniversityUniversity, hospital or other
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 8 Oct 2025 (estimated)
- Study completion
- 8 Oct 2025 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the efficacy and safety of camrelizumab combined with SOX regimen for adjuvant therapy of stage III gastric cancer
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-PD1 combined with SOX | Experimental | Drug: Camrelizumab Combined with SOXCamrelizumab will be administered one day before SOX regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab Combined with SOXAlso: Anti-PD1 Combine with chemotherapyAdminister camrelizumab and SOX regimen in the adjuvant treatment of advanced gastric adenocarcinoma or gastric esophageal junction adenocarcinoma | Drug | Anti-PD1 combined with SOX |
Primary outcome
3 years disease free survival rate
Time frame: 3 years
With 3 years of follow-up,the three-year disease-free survival rate will be observed and compared with the target value.
1 secondary outcome
overall survival time
Time frame: 2 years, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 34102137Janjigian 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.
- Background: PubMed 34515819Hermann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan liu principal investigator
The Second Affiliated Hospital of Shandong First Medical University
1 site in 1 country: see every site and its status.
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.