Adenocarcinoma of the StomachPhase 2NCT05872685
Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)
A Phase 2 study testing S1, Oxaliplatin and Serplulimab in people with Adenocarcinoma of the Stomach and Adenocarcinoma of Esophagogastric Junction, run by Yu jiren at 5 sites in China.
Trial summary
This phase II study is a prospective, multi-center, double-blinded, and randomized trial to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction, Proficient Mismatch Repair
- What is being tested?
- S1, Oxaliplatin and Serplulimab
- 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
- 314 participants
- Where
- 5 sitesChina
- Study dates
- 24 Dec 2023to 30 Apr 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
- The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.
- Gastric or esophagogastric junction adenocarcinoma confirmed by pathology, and proficient mismatch repair confirmed by immunohistochemistry.
- Clinical stage at presentation: cT2-T4b, N+/-, M0 as determined by AJCC staging system, 8th edition.The definition of metastatic lymph nodes: a lymph node must be ≥ 10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm) according to the guideline of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)
- Participants with a performance status of 0 ~ 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.
- Life expectancy ≥ 6 months.
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- Agreement of providing pretreatment endoscopic biopsies specimens and surgical specimens for biomarker analysis, as well as the peripheral blood, feces and urine sample.
- The functions of the vital organs meet requirements as follow (within 14 days before the first dose of study treatment, participant has not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):
- 8.1 Hematological function： White blood cell count (WBC): 3.5 × 10 ^ 9 / L ~12.0 × 10 ^ 9 / L； Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L； Platelet count (PLT) ≥ 100 × 10 ^ 9 / L； Hemoglobin (Hb) ≥ 90 g / L.
- 8.2 Hepatic function： Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal); Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN; Albumin (ALB) ≥ 30 g / L.
- 8.3 Renal function： Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml / min for those with creatinine level > 1.5 × ULN.
- 8.4 Coagulation function： International normalized ratio (INR) ≤ 1.5; Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Female of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of serplulimab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding.
- For the male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of serplulimab, or 180 days after the last dose of chemotherapy, whichever is longer).
Who cannot join
- HER2-positive, EBER-positive or dMMR.
- Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).
- Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).
- Participants with gastric outlet obstruction, or unable for oral take, or severe gastrointestinal bleeding.
- Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).
- Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).
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- Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.
- Participants with active tuberculosis.
- Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.
- Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.
- Participants who need long-term systemic steroid therapy (> 10 mg/d prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.
- Concurrent or previous have severe allergic reaction to any antibody-based drugs.
- Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy.
- Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.
- Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jiren Yu
- Not yet recruiting
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jian Chen
- Not yet recruiting
Lishui Central Hospital
Lishui, Zhejiang, 323000
Hongtao Xu
- Not yet recruiting
Ningbo Medical Center LiHuiLi Hospital
Ningbo, Zhejiang, 315048
Weiming Yu
- Not yet recruiting
Taizhou Hospital
Taizhou, Zhejiang, 317099
Shenkang Zhou
About this study
Official title: Perioperative S-1 Plus Oxaliplatin Combined With Serplulimab or Placebo for Locally Advanced Gastric Adenocarcinoma With Proficient Mismatch Repair: a Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study
This phase II study is a prospective, multi-center, double-blinded, and randomized trial to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair
- Conditions
- Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction, Proficient Mismatch Repair
- Being tested
- S1, Oxaliplatin, Serplulimab, Placebo
- Keywords
- Gastric Adenocarcinoma, Perioperative Chemotherapy, Serplulimab, Proficient mismatch repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1Drug
S-1 orally intake as perioperative chemotherapy
OxaliplatinDrug
Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy
SerplulimabDrug
Perioperative serplulimab, 300 mg IV infusion
PlaceboDrug
Perioperative placebo, 300 mg IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Group A (Chemotherapy+Serplulimab ) | Experimental | Drug: Oxaliplatin，S-1，Serplulimab
Chemotherapy (SOX): Oxaliplatin, administered as a 2-hour intravenous infusion (130 mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery.
Serplulimab: 300 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery. Receives: Drug: S1; Drug: Oxaliplatin; Drug: Serplulimab |
| Group B (Chemotherapy+Placebo ) | Active comparator | Drug: Oxaliplatin，S-1，Placebo
Chemotherapy (SOX): Oxaliplatin, administered as a 2-hour intravenous infusion (130 mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery.
Placebo: 300 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery. Receives: Drug: S1; Drug: Oxaliplatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pathological complete responses (pCR)
Percentage of patients with pCR referring to the total number of enrolled and eligible patients, as evaluated centrally by a reference pathologist.
Measured: From enrollment to surgery after pre-operative treatment (up to approximately 36 months)
Secondary outcomes (3)
Overall survival
Overall survival (OS) will be determined by measuring the time interval from enrollment to the end of follow up or death from any cause
Measured: From enrollment to the end of follow up or death from any cause (up to approximately 60 months)
Progression-free survival
Progression-free survival (PFS) will be defined as the time from enrollment to the end of follow up or the time of disease progression or relapse or death from any cause
Measured: From enrollment to the end of follow up or the time of disease progression or relapse or death from any cause (up to approximately 60 months)
The incidences and types of adverse events (AE) and severe adverse events (SAE)
The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: From enrollment to 90-day after the last dose administration (up to approximately 27 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start24 Dec 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the StomachStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu jiren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu jiren, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872685
- Sponsor's protocol ID
- IIT20230020C-R1
- Status last verified
- Jan 2024
- First submitted
- 14 May 2023
- Last updated
- 17 Jan 2024
- Results posted
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative S-1 Plus Oxaliplatin Combined With Serplulimab or Placebo for Locally Advanced Gastric Adenocarcinoma With Proficient Mismatch Repair: a Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05872685
- Acronym / sponsor ID
- IIT20230020C-R1
- Conditions
- Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction, Proficient Mismatch Repair
- Keywords
- Gastric Adenocarcinoma, Perioperative Chemotherapy, Serplulimab, Proficient mismatch repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Yu jirenUniversity, hospital or other
- Study start
- 24 Dec 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 24 May 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.
This phase II study is a prospective, multi-center, double-blinded, and randomized trial to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Chemotherapy+Serplulimab ) | Experimental | Drug: S1, Drug: Oxaliplatin, Drug: SerplulimabDrug: Oxaliplatin，S-1，Serplulimab Chemotherapy (SOX): Oxaliplatin, administered as a 2-hour intravenous infusion (130 mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery. Serplulimab: 300 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery. |
| Group B (Chemotherapy+Placebo ) | Active comparator | Drug: S1, Drug: Oxaliplatin, Drug: PlaceboDrug: Oxaliplatin，S-1，Placebo Chemotherapy (SOX): Oxaliplatin, administered as a 2-hour intravenous infusion (130 mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery. Placebo: 300 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
- The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.
- Gastric or esophagogastric junction adenocarcinoma confirmed by pathology, and proficient mismatch repair confirmed by immunohistochemistry.
- Clinical stage at presentation: cT2-T4b, N+/-, M0 as determined by AJCC staging system, 8th edition.The definition of metastatic lymph nodes: a lymph node must be ≥ 10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm) according to the guideline of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)
- Participants with a performance status of 0 ~ 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.
Key exclusion criteria (17 listed)
- HER2-positive, EBER-positive or dMMR.
- Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).
- Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).
- Participants with gastric outlet obstruction, or unable for oral take, or severe gastrointestinal bleeding.
- Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).
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 |
|---|---|---|
| S1S-1 orally intake as perioperative chemotherapy | Drug | Group A (Chemotherapy+Serplulimab ), Group B (Chemotherapy+Placebo ) |
| OxaliplatinOxaliplatin (130 mg/m2) infusion as perioperative chemotherapy | Drug | Group A (Chemotherapy+Serplulimab ), Group B (Chemotherapy+Placebo ) |
| SerplulimabPerioperative serplulimab, 300 mg IV infusion | Drug | Group A (Chemotherapy+Serplulimab ) |
| PlaceboPerioperative placebo, 300 mg IV infusion | Drug | Group B (Chemotherapy+Placebo ) |
Primary outcome
Rate of pathological complete responses (pCR)
Time frame: From enrollment to surgery after pre-operative treatment (up to approximately 36 months)
Percentage of patients with pCR referring to the total number of enrolled and eligible patients, as evaluated centrally by a reference pathologist.
3 secondary outcomes
Overall survival
Time frame: From enrollment to the end of follow up or death from any cause (up to approximately 60 months)
Progression-free survival
Time frame: From enrollment to the end of follow up or the time of disease progression or relapse or death from any cause (up to approximately 60 months)
The incidences and types of adverse events (AE) and severe adverse events (SAE)
Time frame: From enrollment to 90-day after the last dose administration (up to approximately 27 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 17 Jan 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S1, Oxaliplatin and Serplulimab in people with Adenocarcinoma of the Stomach and Adenocarcinoma of Esophagogastric Junction, run by Yu jiren at 5 sites 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 14 inclusion and 17 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Jiren Yu (+86-0571-87236147, yujr0909@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pathological complete responses (pCR) (time frame: From enrollment to surgery after pre-operative treatment (up to approximately 36 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 17 Jan 2024.