Gastric CancerPhase 2NCT05975749
Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
A Phase 2 study testing Serplulimab, Trastuzuma and Chemotherapy in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Serplulimab, Trastuzuma and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2029
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower age limit of research subjects 20 years old and upper age limit of 80 years old.
- Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
- R0 gastrectomy with D2 lymphadenectomy
- Her2+ diagnosed by Immunohistochemistry or FISH
- ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
- No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).
Who cannot join
- Patients with stage I and IV.
- Unavailable for R0 resection and D2 lymph node dissection.
- Multiple primary tumors
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- History of chemotherapy, radiotherapy, immunotherapy or target therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 2000000
Dazhi Xu, MD,PHD, 021-64175590, xudzh@shca.org.cn
About this study
Official title: A Study of Compared Adjuvant Serplulimab and Trastuzuma and Chemotherapy vs Chemotherapy Only in Her-2 Positive Gastric Cancer With II-III Stage Following Curative Resection
The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery.
- Conditions
- Gastric Cancer
- Being tested
- Serplulimab, Trastuzuma, Chemotherapy
- Keywords
- Gastric Cancer, Adjuvant treatment, Trastuzuma, Serplulimab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Serplulimab: 4.5mg/Kg on day 1
TrastuzumaDrug
Trastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1
ChemotherapyDrug
Chemotherapy: Capecitabine or S-1 and Oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² or S-1 40 mg/m2 twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy | Experimental | Not described Receives: Drug: Serplulimab; Drug: Trastuzuma; Drug: Chemotherapy |
| Adjuvant Chemotherapy only | Active comparator | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
DFS
Measured: 3-year
Secondary outcomes (2)
Overall survival
OS
Measured: 3-year
Side effects
Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder
Measured: 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dazhi Xu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975749
- Sponsor's protocol ID
- GC-her2
- Status last verified
- Mar 2024
- First submitted
- 27 Jul 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Compared Adjuvant Serplulimab and Trastuzuma and Chemotherapy vs Chemotherapy Only in Her-2 Positive Gastric Cancer With II-III Stage Following Curative Resection
- ClinicalTrials.gov ID
- NCT05975749
- Acronym / sponsor ID
- GC-her2
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Adjuvant treatment, Trastuzuma, Serplulimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 4 Aug 2023 (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.
The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy | Experimental | Drug: Serplulimab, Drug: Trastuzuma, Drug: Chemotherapy |
| Adjuvant Chemotherapy only | Active comparator | Drug: Chemotherapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Lower age limit of research subjects 20 years old and upper age limit of 80 years old.
- Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
- R0 gastrectomy with D2 lymphadenectomy
- Her2+ diagnosed by Immunohistochemistry or FISH
- ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
Key exclusion criteria (5 listed)
- Patients with stage I and IV.
- Unavailable for R0 resection and D2 lymph node dissection.
- Multiple primary tumors
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- History of chemotherapy, radiotherapy, immunotherapy or target therapy.
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 |
|---|---|---|
| SerplulimabSerplulimab: 4.5mg/Kg on day 1 | Drug | Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy |
| TrastuzumaTrastuzuma: 8mg/Kg ( the first cycle)，6mg/Kg (the rest of cycles) on day 1 | Drug | Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy |
| ChemotherapyChemotherapy: Capecitabine or S-1 and Oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² or S-1 40 mg/m2 twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease | Drug | Adjuvant Chemotherapy only, Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy |
Primary outcome
Disease-free survival
Time frame: 3-year
DFS
2 secondary outcomes
Overall survival
Time frame: 3-year
Side effects
Time frame: 12 months]
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 12 Mar 2024.
- 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.
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 Serplulimab, Trastuzuma and Chemotherapy in people with Gastric Cancer, run by Fudan 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Mar 2024. 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?
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?
Disease-free survival (time frame: 3-year). 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 12 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.