Serplulimab,Gastric Cancer, Adjuvant TherapyPhase 2NCT05769725
A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer
A Phase 2 study testing Serplulimab, Docetaxel and S1 in people with Serplulimab,Gastric Cancer, Adjuvant Therapy, run by RenJi Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Serplulimab,Gastric Cancer, Adjuvant Therapy
- What is being tested?
- Serplulimab, Docetaxel and S1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Mar 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
- The patients voluntarily joined the study and signed the informed consent; ≥ 18 years old, ≤ 75 years old, both male and female; Stage III gastric cancer confirmed by pathology, ECoG score: 0-1 Detection of biomarkers in postoperative gastric cancer samples suggests that: PD-L1 + CPS ≥ 5 / MSI-H + / EBV+/dMMR No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment During the study treatment period and within 3 months after the end of the study treatment period, a medically recognized contraceptive measure (such as IUD, contraceptive pill or condom) should be used for the female patients of non-surgical sterilization or childbearing age; the serum or urine HCG test of the female patients of non-surgical sterilization must be negative within 72 hours before the study group; and the hCG test must be non lactation; for the male patients Sex, should be surgical sterilization, or agree to use appropriate methods of contraception during the trial and within 3 months after the last administration of the test drug.
- The baseline blood routine and biochemical indexes of the selected patients should meet the following standards:
- hemoglobin ≥ 90g / L
- absolute neutrophil count ≥ 1.5 × 10 ^ 9 / L
- platelet count ≥ 100 × 10 ^ 9 / L
- ASTor ALT ≤ 2.5 ULN
- Alkaline phosphatase (ALP)≤ 2.5×ULN
- TSH ≤ 1 ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group);
Who cannot join
- Pregnant or lactating women; Women of childbearing age were positive in the baseline pregnancy test; Distant metastasis was diagnosed by CT /MR/ EUS. Received previous anti-tumor treatment, including chemotherapy, radiotherapy or immunotherapy; Have other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer); Uncontrollable pleural effusion, pericardial effusion or ascites; Severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure ≥ level II, uncontrolled arrhythmia and myocardial infarction within 12 months before admission; With gastroduodenal obstruction/bleeding, digestive dysfunction or malabsorption syndrome Complicated with severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury; Allergic reaction to the drugs used in this study; Steroid or other systemic immunosuppressive therapy was used 14 days before admission; Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials).
- Active autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected.
- History of primary immunodeficiency. Immunosuppressive drugs were used within 4 weeks prior to the first dose of study treatment, excluding local or physiological doses of systemic glucocorticoids (i.e. no more than 10mg / day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents.
- Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period.
- Active tuberculosis is known. We have known the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥ 10 ⁴ copies / ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time);.
- Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers. For example, serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, or other family or social factors, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhang Zizhen
Shanghai
zizhen zhang, 216838373
About this study
Official title: A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer(PD-L1 + / MSI-H / EBV +/dMMR)
To evaluate the efficacy and safety of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Secondary study objective: To observe and evaluate the overall survival and adverse events of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1+ / MSI-H / EBV +/dMMR). To evaluate the safety of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage IIIc gastric cancer. To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage IIIc gastric cancer.
- Being tested
- Serplulimab, Docetaxel, S1
- 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
Also called HLX10
Serplulimab, 4.5mg/kg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.
DocetaxelDrug
40 mg/m^2 solution intravenously for 1 hour in first day every 3 weeks. Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle.
S1Drug
Tegafur-gimeracil-oteracil potassium: 50mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab in Combination With Docetaxel +S-1 | Experimental | Not described Receives: Drug: Serplulimab; Drug: Docetaxel; Drug: S1 |
| Docetaxel +S-1 | Placebo comparator | Not described Receives: Drug: Docetaxel; Drug: S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
disease-free survival
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Mar 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serplulimab,Gastric Cancer, Adjuvant TherapyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769725
- Sponsor's protocol ID
- IIT-2023-0001
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 15 Mar 2023
- 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 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer(PD-L1 + / MSI-H / EBV +/dMMR)
- ClinicalTrials.gov ID
- NCT05769725
- Acronym / sponsor ID
- IIT-2023-0001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 15 Mar 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.
To evaluate the efficacy and safety of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Secondary study objective: To observe and evaluate the overall survival and adverse events of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1+ / MSI-H / EBV +/dMMR). To evaluate the safety of Serplulimab in Combination With Docetaxel +S-1 vs. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage IIIc gastric cancer. To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage IIIc gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serplulimab in Combination With Docetaxel +S-1 | Experimental | Drug: Serplulimab, Drug: Docetaxel, Drug: S1 |
| Docetaxel +S-1 | Placebo comparator | Drug: Docetaxel, Drug: S1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patients voluntarily joined the study and signed the informed consent; ≥ 18 years old, ≤ 75 years old, both male and female; Stage III gastric cancer confirmed by pathology, ECoG score: 0-1 Detection of biomarkers in postoperative gastric cancer samples suggests that: PD-L1 + CPS ≥ 5 / MSI-H + / EBV+/dMMR No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment During the study treatment period and within 3 months after the end of the study treatment period, a medically recognized contraceptive measure (such as IUD, contraceptive pill or condom) should be used for the female patients of non-surgical sterilization or childbearing age; the serum or urine HCG test of the female patients of non-surgical sterilization must be negative within 72 hours before the study group; and the hCG test must be non lactation; for the male patients Sex, should be surgical sterilization, or agree to use appropriate methods of contraception during the trial and within 3 months after the last administration of the test drug.
- The baseline blood routine and biochemical indexes of the selected patients should meet the following standards:
- hemoglobin ≥ 90g / L
- absolute neutrophil count ≥ 1.5 × 10 ^ 9 / L
- platelet count ≥ 100 × 10 ^ 9 / L
Key exclusion criteria (7 listed)
- Pregnant or lactating women; Women of childbearing age were positive in the baseline pregnancy test; Distant metastasis was diagnosed by CT /MR/ EUS. Received previous anti-tumor treatment, including chemotherapy, radiotherapy or immunotherapy; Have other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer); Uncontrollable pleural effusion, pericardial effusion or ascites; Severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure ≥ level II, uncontrolled arrhythmia and myocardial infarction within 12 months before admission; With gastroduodenal obstruction/bleeding, digestive dysfunction or malabsorption syndrome Complicated with severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury; Allergic reaction to the drugs used in this study; Steroid or other systemic immunosuppressive therapy was used 14 days before admission; Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials).
- Active autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected.
- History of primary immunodeficiency. Immunosuppressive drugs were used within 4 weeks prior to the first dose of study treatment, excluding local or physiological doses of systemic glucocorticoids (i.e. no more than 10mg / day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents.
- Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period.
- Active tuberculosis is known. We have known the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
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 |
|---|---|---|
| SerplulimabAlso: HLX10Serplulimab, 4.5mg/kg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle. | Drug | Serplulimab in Combination With Docetaxel +S-1 |
| Docetaxel40 mg/m^2 solution intravenously for 1 hour in first day every 3 weeks. Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle. | Drug | Docetaxel +S-1, Serplulimab in Combination With Docetaxel +S-1 |
| S1Tegafur-gimeracil-oteracil potassium: 50mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle. | Drug | Docetaxel +S-1, Serplulimab in Combination With Docetaxel +S-1 |
Primary outcome
DFS
Time frame: 1 years
disease-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Serplulimab,Gastric Cancer, Adjuvant Therapy
Not yet recruitingPhase 2
Adjuvant Treatment With Serplulimab,Trastuzumab and SOX in the HER-2 Positive GC/GEJC
HER2-positive Gastric Cancer
RecruitingPhase 2
Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
Gastric Cancer
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 Serplulimab, Docetaxel and S1 in people with Serplulimab,Gastric Cancer, Adjuvant Therapy, run by RenJi 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 8 inclusion and 7 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 15 Mar 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. Some participants in this study may receive a placebo. 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 zizhen zhang (0086-021-6838373, zzzhang16@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 1 years). 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 15 Mar 2023.