Immune SuppressionPhase 2NCT05739045
Nivolumab Combined With SOX Used in the Perioperative Treatment
A Phase 2 study testing nivolumab combined with SOX in people with Immune Suppression and Gastric Cancer, run by Xiangdong Cheng at 1 site in China.
Trial summary
To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma; Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Suppression, Gastric Cancer
- What is being tested?
- nivolumab combined with SOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2022to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be enrolled in the study:
- 1. Patients voluntarily participate in the study and sign the informed consent form; 2. Age ≥ 18 years and ≤ 75 years; 3. Have pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Patients with gastric or gastroesophageal junction adenocarcinoma at the clinical staging of cT3-4 or N+, M0 (staging according to AJCC version 8) who could be radically resected as determined by CT and laparoscopy; 5. Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Planned surgical treatment after completion of neoadjuvant therapy; 7. Able to swallow tablets normally; 8. ECOG score 0-1; 9. Expected survival >=12 months; 10. Main organ functions normal, i.e., meeting the criteria below:
- Blood routine examination criteria shall meet:
- (No blood transfusion or blood products within 14 days, no G-CSF or other hematopoietic stimulating factors are used for correction) Absolute neutrophil count ≥1.5×109/L; Platelet ≥80×109/L; Hemoglobin ≥ 80 g/L
- Criteria for biochemical tests:
- Total bilirubin <1.5×ULN; ALT and AST≤2.5×ULN;
- Serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance > 50 ml/min (males: Endogenous creatinine clearance rate = ((140-age) × body weight)/(72 × serum Cr); female: endogenous creatinine clearance rate = ((140-age) × body weight)/(72 × serum Cr) × 0.85; body weight unit: kg; serum Cr unit: mg/mL):
- 11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and be willing to use a highly effective method of contraception during the trial and for 120 days after the last dose. Male subjects with partners of childbearing potential should be surgically sterilized or agree to use highly effective methods of contraception during the trial and for 120 days after the last dose;
Who cannot join
- Patients with any of the following are not to be enrolled in the study:
- Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery;
- Previous or concurrent other malignancy;
- Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree of hepatic or renal dysfunction, etc.)
- Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction;
- Patients having clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose of study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or suffering from vasculitis; if stool occult blood is positive at baseline, reexamination may be performed; if stool occult blood remains positive after reexamination, gastroscopy is required (except for patients having gastroscopy within 3 months before enrollment to exclude such condition);
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- Patients in the active stage of infection requiring treatment (such as antibacterial drugs, antiviral drugs, antifungal drugs);
- Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV viral copy number > upper limit of normal);
- Patients with congenital or acquired immunodeficiency (such as HIV infection);
- Patients with any active autoimmune disease or history of autoimmune disease with potential relapse;
- Planned or previous organ or allogeneic bone marrow transplant;
- Patients with current interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring steroids, or subjects with active pneumonia or severe lung function impairment on screening CT; active pulmonary tuberculosis;
- Ongoing or recent treatment with immunosuppressive drugs or systemic corticosteroids to achieve immunosuppression;
- Patients who have received a live attenuated vaccine within 28 days prior to the first dose of study drug or who require administration of such vaccine during treatment or within 60 days after the last dose;
- Patients with known hypersensitivity to any of the study drugs or any of their excipients;
- Nursing mothers;
- Any factors that, in the judgment of the investigator, could affect patient safety and force the termination of the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Cheng Xiangdong, MD, +0086-571-88128041, Chengxd516@126.com
About this study
Official title: A Multicenter, Prospective, Phase Ⅱ Clinical Study of Nivolumab Combined With SOX in the Perioperative Treatment of Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;
Read the detailed description
Primary Objective
- To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma; Secondary Objectives
- To evaluate the major pathological response rate (mPR), R0 resection rate, lymph node status after neoadjuvant therapy (ypN stage), 3-yr-DFS, OS, and safety and tolerability of nivolumab combined with SOX in the periopera; Exploration for markers of benefit groups
- Conditions
- Immune Suppression, Gastric Cancer
- Being tested
- nivolumab combined with SOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumab combined with SOXDrug
nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles);
| Study group | Role | What they receive |
|---|---|---|
| nivolumab combined with SOX | Experimental | Medication regimen: nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles); Surgery is performed 2 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks after surgery. Receives: Drug: nivolumab combined with SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response rate (pCR)
pCR
Measured: 3 months
Secondary outcomes (1)
3-year DFS
3-year DFS
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start3 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SuppressionStudies 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangdong Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
- Investigators
- Cheng Xiangdong, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739045
- Sponsor's protocol ID
- Stimulate-01
- Status last verified
- Jul 2024
- First submitted
- 2 Nov 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Medication regimen: nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles); Surgery is performed 2 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks after surgery.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Phase Ⅱ Clinical Study of Nivolumab Combined With SOX in the Perioperative Treatment of Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05739045
- Acronym / sponsor ID
- Stimulate-01
- Conditions
- Immune Suppression, Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Xiangdong ChengUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Feb 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 pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;
Detailed description
Primary Objective
- To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma; Secondary Objectives
- To evaluate the major pathological response rate (mPR), R0 resection rate, lymph node status after neoadjuvant therapy (ypN stage), 3-yr-DFS, OS, and safety and tolerability of nivolumab combined with SOX in the periopera; Exploration for markers of benefit groups
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nivolumab combined with SOX | Experimental | Drug: nivolumab combined with SOXMedication regimen: nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles); Surgery is performed 2 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Patients voluntarily participate in the study and sign the informed consent form; 2. Age ≥ 18 years and ≤ 75 years; 3. Have pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Patients with gastric or gastroesophageal junction adenocarcinoma at the clinical staging of cT3-4 or N+, M0 (staging according to AJCC version 8) who could be radically resected as determined by CT and laparoscopy; 5. Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Planned surgical treatment after completion of neoadjuvant therapy; 7. Able to swallow tablets normally; 8. ECOG score 0-1; 9. Expected survival >=12 months; 10. Main organ functions normal, i.e., meeting the criteria below:
- Blood routine examination criteria shall meet:
- (No blood transfusion or blood products within 14 days, no G-CSF or other hematopoietic stimulating factors are used for correction) Absolute neutrophil count ≥1.5×109/L; Platelet ≥80×109/L; Hemoglobin ≥ 80 g/L
- Criteria for biochemical tests:
- Total bilirubin <1.5×ULN; ALT and AST≤2.5×ULN;
Key exclusion criteria (17 listed)
- Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery;
- Previous or concurrent other malignancy;
- Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree of hepatic or renal dysfunction, etc.)
- Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction;
- Patients having clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose of study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or suffering from vasculitis; if stool occult blood is positive at baseline, reexamination may be performed; if stool occult blood remains positive after reexamination, gastroscopy is required (except for patients having gastroscopy within 3 months before enrollment to exclude such condition);
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 |
|---|---|---|
| nivolumab combined with SOXnivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles); | Drug | nivolumab combined with SOX |
Primary outcome
pathological complete response rate (pCR)
Time frame: 3 months
pCR
1 secondary outcome
3-year DFS
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Yes. Medication regimen: nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles); Surgery is performed 2 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks after surgery.
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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.
Cheng Xiangdong principal investigator
Zhejiang Cancer 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 nivolumab combined with SOX in people with Immune Suppression and Gastric Cancer, run by Xiangdong Cheng 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 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 9 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Xiangdong (0086-571-881280, Chengxd516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response rate (pCR) (time frame: 3 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 9 Jul 2024.