Gastric CancerPhase 2NCT04782791
Nivolumab, S-1 Combined With Oxaliplatin Versus Nivolumab as Neoadjuvant Therapy in Advanced Gastric Cancer
A Phase 2 study testing Nivolumab plus SOX, Nivolumab and Gastrectomy in people with Gastric Cancer and Chemotherapy Effect, run by Chinese PLA General Hospital.
Trial summary
The trial is a prospective, randomized, controlled phase Ⅱ study which will be conducted in Chinese PLA General Hospital, Beijing, China. Patients with eligibility will enrolled and assigned into either group A for 9 weeks of nivolumab, S-1 combined with oxaliplatin (Nivo+SOX) followed by D2 surgery and group B for 9… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Chemotherapy Effect
- What is being tested?
- Nivolumab plus SOX, Nivolumab and Gastrectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-bedridden, aged 18 to 70 years old;
- Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
- Histologically confirmed gastric adenocarcinoma;
- Have evaluable lesions based on RECIST 1.1;
- Stage III (cT3-4aN1-3 M0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cancer confirmed by enhanced computer tomography (enhanced CT) and laparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) if necessary);
- The surgeon have the ability to complete standard D2 radical gastrectomy and the gastrectomy can be tolerated by the patient;
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- Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophil absolute count ≥ 3× 109 /L, platelet count (PLT) ≥ 100× 109 /L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN, serum creatinine (SCr) ≤ 1.5×ULN, and serum albumin (ALB) ≥ 30 g/L;
- Patients with heart disease, echocardiogram showing that the left ventricular ejection fraction ≥ 50%, electrocardiogram (ECG) is basically normal within 4 weeks before operation and with no obvious symptoms are acceptable;
- There is no serious underlying disease that could lead to an expected life expectancy < 5 years;
- Willing to sign the informed consent for participation and publication of results.
Who cannot join
- Human epidermal growth factor receptor 2 (HER2)-positive or indeterminate G/GEJ cancer;
- Pregnant or lactating women;
- Positive pregnancy test for women in childbearing age. Menopausal women without menstruation for at least 12 months can be regarded as women with no possibility of getting pregnant;
- Refusal of birth control during the study;
- Prior chemotherapy, radiotherapy or immunotherapy;
- History of other malignant diseases in the last 5 years (except for cervical carcinoma in situ);
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- History of uncontrolled central nervous system diseases, which could influence the compliance;
- History of severe liver diseases (Child-Pugh class C), renal diseases (endogenous creatinine clearance rate (Ccr) ≤ 50 ml/min or SCr > 1.5 ULN) or respiratory diseases; Uncontrolled diabetes and hypertension; Clinically severe heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, uncontrolled arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 6 months;
- History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation;
- On steroid treatment after organ transplant;
- With uncontrolled severe infections;
- Known dihydropyrimidine dehydrogenase deficiency (DPD);
- Anaphylaxis to any research drug ingredient;
- Known peripheral neuropathy (> NCI-CTC AE 1). Patients with only disappearance of deep tendon reflex need not to be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Randomized, Controlled Phase II Evaluation of Nivolumab, S-1 Combined With Oxaliplatin (Nivo+SOX) Versus Nivolumab (Nivo) as Neoadjuvant Therapy in Patients With Locally Advanced Gastric Adenocarcinoma (RESONANCE-Ⅲ Study)
The trial is a prospective, randomized, controlled phase Ⅱ study which will be conducted in Chinese PLA General Hospital, Beijing, China. Patients with eligibility will enrolled and assigned into either group A for 9 weeks of nivolumab, S-1 combined with oxaliplatin (Nivo+SOX) followed by D2 surgery and group B for 9 weeks of nivolumab followed by D2 surgery. The primary endpoint is the safety assessed by recording adverse events and the secondary endpoints are response rate, disease control rate, pathological complete response rate, D2 rate and R0 rate.
- Conditions
- Gastric Cancer, Chemotherapy Effect
- Being tested
- Nivolumab plus SOX, Nivolumab, Gastrectomy
- 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 plus SOXDrug
Also called Nivo + SOX
The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg and oxaliplatin 130mg/m2 on day 1, and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14. The dose of S-1 depends on body surface area (BSA): BSA<1.25 m2, 40mg; 1.25<BSA<1.50 m2, 50mg; BSA>1.50 m2, 60mg. Day 15 to day 21 is the rest period.
NivolumabDrug
Also called Nivo
The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg on day 1.
GastrectomyProcedure or surgery
A standard D2 radical laparoscopic gastrectomy according to the CSCO clinical guidelines for the diagnosis and treatment of gastric cancer is planned 3-4 weeks after the last cycle of preoperative therapy.
| Study group | Role | What they receive |
|---|---|---|
| Nivo + SOX | Experimental | Nivolumab plus SOX Receives: Drug: Nivolumab plus SOX; Procedure: Gastrectomy |
| Nivo | Active comparator | Nivolumab Receives: Drug: Nivolumab; Procedure: Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The safety is assessed by recording adverse events.
Measured: 2 years
Secondary outcomes (5)
RR
Response rate, defined as the rate of patients who achieve CR or PR according to the RESIST 1.1.
Measured: 2 years
DCR
Disease control rate, defined as the rate of patients who achieve CR, PR or PD according to the RESIST 1.1.
Measured: 2 years
pCR rate
Pathological complete response rate, defined as the rate of patients achieving pathological complete response.
Measured: 2 years
D2 rate
The rate of patients who received D2 radical gastrectomy.
Measured: 2 years
R0 rate
The rate of patients who received R0 resection.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 May 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 May 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 Chinese PLA General 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782791
- Sponsor's protocol ID
- R3
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Phase II Evaluation of Nivolumab, S-1 Combined With Oxaliplatin (Nivo+SOX) Versus Nivolumab (Nivo) as Neoadjuvant Therapy in Patients With Locally Advanced Gastric Adenocarcinoma (RESONANCE-Ⅲ Study)
- ClinicalTrials.gov ID
- NCT04782791
- Acronym / sponsor ID
- R3
- Conditions
- Gastric Cancer, Chemotherapy Effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 4 Mar 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.
The trial is a prospective, randomized, controlled phase Ⅱ study which will be conducted in Chinese PLA General Hospital, Beijing, China. Patients with eligibility will enrolled and assigned into either group A for 9 weeks of nivolumab, S-1 combined with oxaliplatin (Nivo+SOX) followed by D2 surgery and group B for 9 weeks of nivolumab followed by D2 surgery. The primary endpoint is the safety assessed by recording adverse events and the secondary endpoints are response rate, disease control rate, pathological complete response rate, D2 rate and R0 rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivo + SOX | Experimental | Drug: Nivolumab plus SOX, Procedure: GastrectomyNivolumab plus SOX |
| Nivo | Active comparator | Drug: Nivolumab, Procedure: GastrectomyNivolumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non-bedridden, aged 18 to 70 years old;
- Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
- Histologically confirmed gastric adenocarcinoma;
- Have evaluable lesions based on RECIST 1.1;
- Stage III (cT3-4aN1-3 M0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cancer confirmed by enhanced computer tomography (enhanced CT) and laparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) if necessary);
Key exclusion criteria (14 listed)
- Human epidermal growth factor receptor 2 (HER2)-positive or indeterminate G/GEJ cancer;
- Pregnant or lactating women;
- Positive pregnancy test for women in childbearing age. Menopausal women without menstruation for at least 12 months can be regarded as women with no possibility of getting pregnant;
- Refusal of birth control during the study;
- Prior chemotherapy, radiotherapy or immunotherapy;
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 plus SOXAlso: Nivo + SOXThe preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg and oxaliplatin 130mg/m2 on day 1, and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14. The dose of S-1 depends on body surface area (BSA): BSA<1.25 m2, 40mg; 1.25<BSA<1.50 m2, 50mg; BSA>1.50 m2, 60mg. Day 15 to day 21 is the rest period. | Drug | Nivo + SOX |
| NivolumabAlso: NivoThe preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg on day 1. | Drug | Nivo |
| GastrectomyA standard D2 radical laparoscopic gastrectomy according to the CSCO clinical guidelines for the diagnosis and treatment of gastric cancer is planned 3-4 weeks after the last cycle of preoperative therapy. | Procedure or surgery | Nivo, Nivo + SOX |
Primary outcome
Adverse events
Time frame: 2 years
The safety is assessed by recording adverse events.
5 secondary outcomes
RR
Time frame: 2 years
DCR
Time frame: 2 years
pCR rate
Time frame: 2 years
D2 rate
Time frame: 2 years
R0 rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab plus SOX, Nivolumab and Gastrectomy in people with Gastric Cancer and Chemotherapy Effect, run by Chinese PLA General Hospital.
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 10 inclusion and 14 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Xinxin Wang, Dr. (+8613811858199, 301wxx@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 2 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 11 Jan 2022.