Stomach NeoplasmsPhase 2NCT05602935
Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
A Phase 2 study testing Camrelizumab, SOX and Surgery in people with Stomach Neoplasms and Digestive System Neoplasms, run by The Second Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Digestive System Neoplasms, Neoplasms
- What is being tested?
- Camrelizumab, SOX and Surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2020to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age older than 18 years of age;
- Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma;
- Without prior systematic therapy;
- The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1;
- With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS;
- Life expectancy longer than 12 months;
- Adequate function of blood, heart, liver, kidney and thyroid.
Who cannot join
- History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
- Unresectable tumor evaluated by investigator;
- Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
- With tumors in other sites;
- History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may not be included;
- Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin;
- With any mental illness;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
About this study
This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.
- Conditions
- Stomach Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Stomach Diseases, Neoplasms by Site
- Being tested
- Camrelizumab, SOX, Surgery
- Keywords
- gastric cancer, neoadjuvant chemoimmunotherapy, neoadjuvant immunotherapy
- Medical subject headings
- Stomach Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Stomach Diseases, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
200mg, intravenously, d1
SOXDrug
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
SurgeryProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+SOX | Experimental | The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin). Receives: Drug: Camrelizumab; Drug: SOX; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR) rate
The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR)
Measured: 2-4 months
Secondary outcomes (7)
R0 resection rate
Measured: 2-4 months
Overall response rate(ORR)
Measured: 2-4 months
Disease control rate(DCR)
Measured: 2-4 months
Major pathological response (MPR)
The AJCC TRG system was used in this study to determine the effects of treatment.
Measured: 2-4 months
Adverse events (AE) rate
Measured: 3 years
Event-free survival(EFS)
Measured: 3 years
Overall survival(OS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start16 Sep 2020
- Primary completion30 Mar 2022
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies 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
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602935
- Sponsor's protocol ID
- NEO-GASTRIC
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhong WJ, Lin JA, Wu CY, Wang J, Chen JX, Zheng H, Ye K. Efficacy and safety of camrelizumab combined with oxaliplatin and S-1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single-arm study. Cancer Med. 2024 Feb;13(3):e7006. doi: 10.1002/cam4.7006.
PubMed 38400680
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study
- ClinicalTrials.gov ID
- NCT05602935
- Acronym / sponsor ID
- NEO-GASTRIC
- Conditions
- Stomach Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Stomach Diseases, Neoplasms by Site
- Keywords
- gastric cancer, neoadjuvant chemoimmunotherapy, neoadjuvant immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Nov 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.
This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+SOX | Experimental | Drug: Camrelizumab, Drug: SOX, Procedure: SurgeryThe patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age older than 18 years of age;
- Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma;
- Without prior systematic therapy;
- The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1;
- With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
Key exclusion criteria (8 listed)
- History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
- Unresectable tumor evaluated by investigator;
- Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
- With tumors in other sites;
- History of any active autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypohysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy);Patients with psoriasis or childhood asthma/allergy who have been in complete remission and do not need any intervention as adults may be considered for inclusion, but patients requiring medical intervention with bronchodilators may 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 |
|---|---|---|
| Camrelizumab200mg, intravenously, d1 | Drug | Camrelizumab+SOX |
| SOXSOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle) | Drug | Camrelizumab+SOX |
| SurgerySurgery | Procedure or surgery | Camrelizumab+SOX |
Primary outcome
Pathologic complete response (pCR) rate
Time frame: 2-4 months
The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR)
7 secondary outcomes
R0 resection rate
Time frame: 2-4 months
Overall response rate(ORR)
Time frame: 2-4 months
Disease control rate(DCR)
Time frame: 2-4 months
Major pathological response (MPR)
Time frame: 2-4 months
Adverse events (AE) rate
Time frame: 3 years
Event-free survival(EFS)
Time frame: 3 years
Overall survival(OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 38400680Zhong WJ, Lin JA, Wu CY, Wang J, Chen JX, Zheng H, Ye K. Efficacy and safety of camrelizumab combined with oxaliplatin and S-1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single-arm study. Cancer Med. 2024 Feb;13(3):e7006. doi: 10.1002/cam4.7006.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, SOX and Surgery in people with Stomach Neoplasms and Digestive System Neoplasms, run by The Second Affiliated Hospital of Fujian 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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pathologic complete response (pCR) rate (time frame: 2-4 months). 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 NCT05602935, which also lists 1 linked publication.
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 Sep 2023.