Efficacy and Safty of Camrelizumab Plus S-1 Maintenance After First-line Induction Chemotherapy for GCPhase 2NCT05170542
The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma.
A Phase 2 study testing Camrelizumab+S-1 in people with Efficacy and Safty of Camrelizumab Plus S-1 Maintenance After First-line Induction Chemotherapy for GC, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
In this study, We investigated the efficacy and safty of camrelizumab combined with S-1 maintenance after first-line induction chemotherapy for GC. Patients without progressive disease after 4-6 weeks of first-line chemotherapy with SOX will be treated with camrelizumab combined with S-1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Efficacy and Safty of Camrelizumab Plus S-1 Maintenance After First-line Induction Chemotherapy for GC
- What is being tested?
- Camrelizumab+S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2021to 24 Jan 2026
- 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
- Male or female subjects aged from 18 to 75 years old;
- Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
- Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- Estimated life expectancy of more than 3 months;
- Adequate haematological, hepatic and renal functions defined by the protocol;
- Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for both male and female subjects if the risk of conception exists;
Who cannot join
- Concurrent anticancer treatment such as chemotherapy, radiotherapy, targeted or immunotherapy;
- Tumor shown to be human epidermal growth factor 2 plus (HER2+);
- Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast);
- Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever (>38.5%) of unknown reason occurred during the screening period/before the first administration；
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
- Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
Show all 10Show fewer
- Used immunosuppressive drugs within 14 days before the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;
- Accination with live or live/attenuated viruses within 28 days of the first dose of camrelizumab and while on trial is prohibited except for administration of inactivated vaccines;
- History of uncontrolled intercurrent illness including hypertension, active infection, diabetes or cardiac diseases or symptoms;
- Prior organ transplantation, including allogeneic stem-cell transplantation； Other protocol-defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lin Zhao
Beijing, Beijing Municipality, 100032
Lin Zhao, PhD, 010-69158754, wz20010727@aliyun.com
About this study
Official title: A Single-arm, Phase II Study of Camrelizumab Combined With S-1 Maintenance After First-Line Induction Chemotherapy in Patients With HER2 Negative Advanced Gastric Cancer
In this study, We investigated the efficacy and safty of camrelizumab combined with S-1 maintenance after first-line induction chemotherapy for GC. Patients without progressive disease after 4-6 weeks of first-line chemotherapy with SOX will be treated with camrelizumab combined with S-1.
- Being tested
- Camrelizumab+S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab+S-1Drug
Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+S-1 | Experimental | Not described Receives: Drug: Camrelizumab+S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment.
Measured: From the start of randomization to a minimum of 42 months
Secondary outcomes (4)
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 3.5 years
Objective Response Rate（ORR）
Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
Measured: From the start of randomization to a minimum of 42 months
Disease Control Rate (DCR)
Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.
Measured: Time Frame: From the start of randomization to a minimum of 42 months
Overall Survival（OS）
OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death.
Measured: From the start of randomization to a minimum of 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start24 Dec 2021 (estimated)
- Primary completion24 Dec 2025 (estimated)
- Study completion24 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and Safty of Camrelizumab Plus S-1 Maintenance After First-line Induction Chemotherapy for GCStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WangXiang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170542
- Sponsor's protocol ID
- MA-GC-Ⅱ-09
- Status last verified
- Dec 2021
- First submitted
- 24 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Study of Camrelizumab Combined With S-1 Maintenance After First-Line Induction Chemotherapy in Patients With HER2 Negative Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT05170542
- Acronym / sponsor ID
- MA-GC-Ⅱ-09
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Dec 2021 (estimated)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 24 Jan 2026 (estimated)
- First posted
- 28 Dec 2021 (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.
In this study, We investigated the efficacy and safty of camrelizumab combined with S-1 maintenance after first-line induction chemotherapy for GC. Patients without progressive disease after 4-6 weeks of first-line chemotherapy with SOX will be treated with camrelizumab combined with S-1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+S-1 | Experimental | Drug: Camrelizumab+S-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged from 18 to 75 years old;
- Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ);
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
- Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- Estimated life expectancy of more than 3 months;
Key exclusion criteria (10 listed)
- Concurrent anticancer treatment such as chemotherapy, radiotherapy, targeted or immunotherapy;
- Tumor shown to be human epidermal growth factor 2 plus (HER2+);
- Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast);
- Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever (>38.5%) of unknown reason occurred during the screening period/before the first administration；
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
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+S-1Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. | Drug | Camrelizumab+S-1 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the start of randomization to a minimum of 42 months
PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment.
4 secondary outcomes
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time frame: From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 3.5 years
Objective Response Rate（ORR）
Time frame: From the start of randomization to a minimum of 42 months
Disease Control Rate (DCR)
Time frame: Time Frame: From the start of randomization to a minimum of 42 months
Overall Survival（OS）
Time frame: From the start of randomization to a minimum of 42 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: Undecided
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.
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+S-1 in people with Efficacy and Safty of Camrelizumab Plus S-1 Maintenance After First-line Induction Chemotherapy for GC, run by Peking Union Medical College 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 7 inclusion and 10 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 28 Dec 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the start of randomization to a minimum of 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2021.