Gastric CancerPhase 2NCT04982939
Peri-operative Sintilimab in Combination With SOX in Locally Advanced Gastric Cancer
A Phase 2 study testing Sintilimab, S-1 and Oxaliplatin in people with Gastric Cancer and Perioperative, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To evaluate efficacy and safety of peri-operative sintilimab in combination with SOX in resectable locally advanced gastric or gastroesophageal junction adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Perioperative, Sintilimab
- What is being tested?
- Sintilimab, S-1 and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2021to 21 Jun 2024
- 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, 18 years old ≤ age ≤ 75 years old
- ECOG PS score 0-1
- Treatment naive patients diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma by histopathology
- No known HER2-positive status;
- Clinical stage Ⅱ, Ⅲ (T1-4a N+ M0, T3-4a N0 M0, AJCC 8th)
- The research center and the surgeon can complete D2 radical gastrectomy
Show all 17Show fewer
- Physical condition and organ function allow for larger abdominal surgery
- Sufficient organ and bone marrow function, which is defined as follows:
- Blood routine: absolute neutrophil count (ANC)≥1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin content (HGB)≥9.0 g/dL.
- Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ×ULN;
- Renal function: Creatinine clearance rate (Ccr) ≥50 mL/min (calculated by Cockcroft/Gault formula):
- Female: Ccr= (140-years old) x weight (kg) x 0.85/(72 x serum creatinine (mg/dL))
- Male: Ccr= (140-years old) x weight (kg) x 1.00/(72 x serum creatinine (mg/dL))
- The coagulation function is adequate, defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the proposed range of anticoagulation drugs
- LVEF≥50%;
- Agree and be able to comply with the plan during the research period;
- Provide written informed consent before entering the study screening, and the patient has understood that participants can withdraw from the study at any time during the study without any loss;
Who cannot join
- Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome;
- Complicated with severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe renal injury;
- Received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.;
- Suffered from 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;
- Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction;
Show all 17Show fewer
- Allergic reactions to the drugs used in this study;
- Use steroids or other systemic immunosuppressive therapies 14 days before enrollment;
- Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials);
- Active autoimmune diseases;
- History of primary immunodeficiency;
- Have used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal spray, inhaled or other local glucocorticoids or physiological doses of systemic glucocorticoids (that is, no more than 10 mg/day Pred nisone or other glucocorticoids in equivalent doses), or use hormones to prevent allergy to contrast agents;
- Within 4 weeks before the first dose of study treatment or plan to receive live attenuated vaccine during the study period;
- Known to have active tuberculosis;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- HIV antibody positive, active hepatitis B or C (HBV, HCV);
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Xuewei Ding, PhD., 18622220158, xding@tmu.edu.cn
About this study
Official title: Efficacy and Safety of Peri-operative Sintilimab in Combination With SOX in Resectable Locally Advanced Gastric Cancer: a Multiple-center Open-label Randomized Phase II Trial.
To evaluate efficacy and safety of peri-operative sintilimab in combination with SOX in resectable locally advanced gastric or gastroesophageal junction adenocarcinoma
- Conditions
- Gastric Cancer, Perioperative, Sintilimab
- Being tested
- Sintilimab, S-1, Oxaliplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called IBI308
Sintilimab, 200mg IV d1 Q3W
S-1Drug
S-1, 40-60mg BID d1-14 Q3W
OxaliplatinDrug
Oxaliplatin，130mg/m2 d1 Q3W
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group-Sintilimab in combination with SOX | Experimental | Preoperative treatment: three cycles of sintilimab in combination with SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX, Sintilimab up to one year. Receives: Drug: Sintilimab; Drug: S-1; Drug: Oxaliplatin |
| Active Comparator-SOX | Active comparator | Preoperative treatment: three cycles of SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX. Receives: Drug: S-1; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
Measured: up to 8 weeks after surgery
Secondary outcomes (7)
Tumor down-staging rate
Tumor down-staging is defined as any stage reduction between clinical and pathologic stage
Measured: up to 8 weeks after surgery
Major pathological response (MPR) rate
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to < 10%, as determined by a pathologist.
Measured: up to 8 weeks after surgery
3 years disease-free survival (DFS) rate
3 years disease-free survival (DFS) rate is defined as proportion of participants who have no recurrence or metastasis after 3 years of radical treatment
Measured: up to 4 years
5 years overall survival (OS) rate
5 years overall survival (OS) rate is defined as proportion of participants who survived 5 years after radical treatment
Measured: up to 6 years
Adverse event
All grades of adverse events, all grades of treatment related adverse events, serious of adverse events
Measured: up to 30 days after last treatment administration
Overall response rate ( ORR)
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
Measured: up to 30 days after last preoperative treatment administration
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD
Measured: up to 30 days after last preoperative treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start21 Jun 2021
- Primary completion21 Jun 2023 (estimated)
- Study completion21 Jun 2024 (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 Tianjin Medical University Cancer Institute and 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han Liang, PhD., Principal investigator, Tianjin Medical University Cancer Institute and HospitalXuewei Ding, PhD., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982939
- Sponsor's protocol ID
- PERSIST
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Peri-operative Sintilimab in Combination With SOX in Resectable Locally Advanced Gastric Cancer: a Multiple-center Open-label Randomized Phase II Trial.
- ClinicalTrials.gov ID
- NCT04982939
- Acronym / sponsor ID
- PERSIST
- Conditions
- Gastric Cancer, Perioperative, Sintilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 21 Jun 2023 (estimated)
- Study completion
- 21 Jun 2024 (estimated)
- First posted
- 29 Jul 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.
To evaluate efficacy and safety of peri-operative sintilimab in combination with SOX in resectable locally advanced gastric or gastroesophageal junction adenocarcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group-Sintilimab in combination with SOX | Experimental | Drug: Sintilimab, Drug: S-1, Drug: OxaliplatinPreoperative treatment: three cycles of sintilimab in combination with SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX, Sintilimab up to one year. |
| Active Comparator-SOX | Active comparator | Drug: S-1, Drug: OxaliplatinPreoperative treatment: three cycles of SOX. Radical gastrectomy and lymphadenectomy (D2). Postoperative treatment: five cycles of SOX. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female, 18 years old ≤ age ≤ 75 years old
- ECOG PS score 0-1
- Treatment naive patients diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma by histopathology
- No known HER2-positive status;
- Clinical stage Ⅱ, Ⅲ (T1-4a N+ M0, T3-4a N0 M0, AJCC 8th)
Key exclusion criteria (17 listed)
- Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome;
- Complicated with severe uncontrolled concurrent infection or other severe uncontrolled concomitant disease, moderate or severe renal injury;
- Received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.;
- Suffered from 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;
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 |
|---|---|---|
| SintilimabAlso: IBI308Sintilimab, 200mg IV d1 Q3W | Drug | Experimental Group-Sintilimab in combination with SOX |
| S-1S-1, 40-60mg BID d1-14 Q3W | Drug | Active Comparator-SOX, Experimental Group-Sintilimab in combination with SOX |
| OxaliplatinOxaliplatin，130mg/m2 d1 Q3W | Drug | Active Comparator-SOX, Experimental Group-Sintilimab in combination with SOX |
Primary outcome
Pathological complete response (pCR) rate
Time frame: up to 8 weeks after surgery
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
7 secondary outcomes
Tumor down-staging rate
Time frame: up to 8 weeks after surgery
Major pathological response (MPR) rate
Time frame: up to 8 weeks after surgery
3 years disease-free survival (DFS) rate
Time frame: up to 4 years
5 years overall survival (OS) rate
Time frame: up to 6 years
Adverse event
Time frame: up to 30 days after last treatment administration
Overall response rate ( ORR)
Time frame: up to 30 days after last preoperative treatment administration
Disease Control Rate (DCR)
Time frame: up to 30 days after last preoperative treatment administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Han Liang, PhD. principal investigator
Tianjin Medical University Cancer Institute and Hospital
Xuewei Ding, PhD. principal investigator
Tianjin Medical University Cancer Institute and Hospital
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 Sintilimab, S-1 and Oxaliplatin in people with Gastric Cancer and Perioperative, run by Tianjin Medical University Cancer Institute and 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 17 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: status not confirmed, as of the sponsor's last update on 31 Aug 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?
Contact Xuewei ding, PhD. (18622220158, xding@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: up to 8 weeks after surgery). 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 31 Aug 2021.