Immune-related Adverse EventNCT06440811
Efficacy and Safety of Neoadjuvant Nivolumab Plus SOX Versus Nivolumab Plus FLOT in Patients With HER2-negative Gastric and Gastroesophageal Junction Adenocarcinoma
An observational study of Immune-related Adverse Event and Chemotherapeutic Toxicity, run by Xijing Hospital at 3 sites in China.
Trial summary
The goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT Regimen with nivolumab in HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune-related Adverse Event, Chemotherapeutic Toxicity, Gastric or Gastroesophageal Junction Adenocarcinoma
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2021to 30 Dec 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: The patients came from several tertiary hospitals in Xi'an city, Shaanxi Province, and were diagnosed with locally advanced gastric cancer, and the patients would accept either the neoadjuvant SOX+nivolumab or FLOT+nivolumab regimen.
Who may be able to join
- 1. Histopathological confirmation of GC or GEJC.
- 2. Absence of prior anti-tumor treatments, encompassing surgical resection, chemotherapy, radiotherapy, or immunotherapy.
- 3. Age within the range of 18 to 75 years.
- 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
- 5. Absence of concurrent malignancies.
- 6. For patients with resectable GC, those with locally advanced stage III and IVA were clearly included according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system, and there were no unresectable factors.
- 7. Patients with HER-2 negative.
- 8. Basal information such as hematology and pathological histology was complete.
Who cannot join
- 1. Refusal of surgical resection subsequent to neoadjuvant therapy.
- 2. Receipt of other ICIs during the study period.
- 3. Receipt of corticosteroids during the study period.
- 4. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
- 5. Confirmed recurrence of GC.
- 6. Hypersensitivity to the study medication.
Show all 25Show fewer
- 7. Systemic medical conditions contraindicating chemotherapy.
- 8. Psychiatric illnesses contraindicating chemotherapy.
- 9. Acute infections necessitating antibiotic therapy.
- 10. Uncontrolled diabetes mellitus.
- 11. Metastatic disease.
- 12. Severe malnutrition.
- 13. Active autoimmune disorders.
- 14. Pregnancy or lactation.
- 15. Positive serological test for hepatitis B or C virus infection,
- 16. Untreated central nervous system metastases peripheral neuropathy.
- 17. Severe myelosuppression.
- 18. Severe hepatic or renal insufficiency (Child-Pugh C, estimated glomerular filtration rate [eGFR] <30 mL/min).
- 19. Significant cardiac history.
- 20. Patients with a history of allogeneic organ transplantation.
- 21. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
- 22. Patients with multiple factors affecting oral medication.
- 23. Vaccination within 4 weeks prior to the first dose of study drug.
- 24. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
- 25. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Tangdu hospital
Xi'an, Shaanxi, 710032
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi
Xijing hospital
Xi'an, Shaanxi
About this study
Official title: Efficacy and Safety of Neoadjuvant Nivolumab Plus SOX Versus Nivolumab Plus FLOT in Patients With HER2-negative Gastric and Gastroesophageal Junction Adenocarcinoma: A Multicentre, Open-Label, Prospective Cohort Study
The goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT Regimen with nivolumab in HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma. The main question it aims to answer are:
- Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT regimen with nivolumab for the treatment of HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma.
- Disease-free survival of preoperative adjuvant SOX plus nivolumab and FLOT plus nivolumab for HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma.
Participants will be divided into two groups to use a FLOT chemotherapy regimen plus nivolumab (one group) and a SOX chemotherapy regimen plus nivolumab (another group). Researchers would compare tumor regression grade, adverse effects and survival benefit of two neoadjuvant regimens.
- Conditions
- Immune-related Adverse Event, Chemotherapeutic Toxicity, Gastric or Gastroesophageal Junction Adenocarcinoma
- Keywords
- neoadjuvant chemotherapy, Nivolumab, SOX, FLOT, locally advanced, HER-negative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FLOT+nivolumab | Patients in the FLOT group received 4 cycles of standard FLOT chemotherapy, the FLOT chemotherapy cycle consists of: day 1: intravenous 5-FU 2600 mg/m² inserted through a peripherally inserted central catheter (PICC) for 24 hours intravenous folic acid 200 mg/m2 intravenous oxaliplatin 85 mg/m² intravenous docetaxel 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Nivolumab (360 mg) was administered intravenously (IV) over 30 minutes once every 3 weeks for 6 weeks (1 cycle, 2 doses). | |
| SOX+nivolumab | Patients in the SOX group received 3 cycles of S-1 + OXA chemotherapy prior to radical gastrectomy.The SOX chemotherapy cycle consists of: day 1: intravenous OXA 130 mg/m² days 1-14: oral S-1 80 mg/m², 2 times/Day. Repeat next chemotherapy on day 22. Nivolumab (360 mg) was administered intravenously (IV) over 30 minutes once every 3 weeks for 6 weeks (1 cycle, 2 doses). |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse event
adverse event caused by FLOT, SOX or nivolumab treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events
Measured: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
Secondary outcomes (4)
tumor regression grade
Residual tumor components in post-radiotherapy samples and the proportion of fibrosis
Measured: From the surgery to evaluation of tumor regression grade, assessed up to 1 week
disease-free survival
from diagnosis to recurrence or death
Measured: From date of diagnosis until the first documented recurrence or death, assessed up to 120 months
objective response rate
objective response rate defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: From the surgery to evaluation of objective response rate, assessed up to 1 week
Duration of response
Duration of response
Measured: From the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause, assessed up to 120 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jan 2021
- Primary completion1 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-related Adverse EventStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jipeng Li, Doctor, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440811
- Sponsor's protocol ID
- loong-101
- Status last verified
- May 2025
- First submitted
- 6 Apr 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neoadjuvant Nivolumab Plus SOX Versus Nivolumab Plus FLOT in Patients With HER2-negative Gastric and Gastroesophageal Junction Adenocarcinoma: A Multicentre, Open-Label, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06440811
- Acronym / sponsor ID
- loong-101
- Conditions
- Immune-related Adverse Event, Chemotherapeutic Toxicity, Gastric or Gastroesophageal Junction Adenocarcinoma
- Keywords
- neoadjuvant chemotherapy, Nivolumab, SOX, FLOT, locally advanced, HER-negative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 4 Jun 2024 (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 goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT Regimen with nivolumab in HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma. The main question it aims to answer are:
- Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT regimen with nivolumab for the treatment of HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma.
- Disease-free survival of preoperative adjuvant SOX plus nivolumab and FLOT plus nivolumab for HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma.
Participants will be divided into two groups to use a FLOT chemotherapy regimen plus nivolumab (one group) and a SOX chemotherapy regimen plus nivolumab (another group). Researchers would compare tumor regression grade, adverse effects and survival benefit of two neoadjuvant regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLOT+nivolumab | – | –Patients in the FLOT group received 4 cycles of standard FLOT chemotherapy, the FLOT chemotherapy cycle consists of: day 1: intravenous 5-FU 2600 mg/m² inserted through a peripherally inserted central catheter (PICC) for 24 hours intravenous folic acid 200 mg/m2 intravenous oxaliplatin 85 mg/m² intravenous docetaxel 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Nivolumab (360 mg) was administered intravenously (IV) over 30 minutes once every 3 weeks for 6 weeks (1 cycle, 2 doses). |
| SOX+nivolumab | – | –Patients in the SOX group received 3 cycles of S-1 + OXA chemotherapy prior to radical gastrectomy.The SOX chemotherapy cycle consists of: day 1: intravenous OXA 130 mg/m² days 1-14: oral S-1 80 mg/m², 2 times/Day. Repeat next chemotherapy on day 22. Nivolumab (360 mg) was administered intravenously (IV) over 30 minutes once every 3 weeks for 6 weeks (1 cycle, 2 doses). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients came from several tertiary hospitals in Xi'an city, Shaanxi Province, and were diagnosed with locally advanced gastric cancer, and the patients would accept either the neoadjuvant SOX+nivolumab or FLOT+nivolumab regimen.
Key inclusion criteria (8 listed)
- 1. Histopathological confirmation of GC or GEJC.
- 2. Absence of prior anti-tumor treatments, encompassing surgical resection, chemotherapy, radiotherapy, or immunotherapy.
- 3. Age within the range of 18 to 75 years.
- 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
- 5. Absence of concurrent malignancies.
Key exclusion criteria (25 listed)
- 1. Refusal of surgical resection subsequent to neoadjuvant therapy.
- 2. Receipt of other ICIs during the study period.
- 3. Receipt of corticosteroids during the study period.
- 4. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
- 5. Confirmed recurrence of GC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adverse event
Time frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
adverse event caused by FLOT, SOX or nivolumab treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events
4 secondary outcomes
tumor regression grade
Time frame: From the surgery to evaluation of tumor regression grade, assessed up to 1 week
disease-free survival
Time frame: From date of diagnosis until the first documented recurrence or death, assessed up to 120 months
objective response rate
Time frame: From the surgery to evaluation of objective response rate, assessed up to 1 week
Duration of response
Time frame: From the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause, assessed up to 120 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- 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. This study is not recruiting at the moment.
Jipeng Li, Doctor principal investigator
Xijing Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune-related Adverse Event and Chemotherapeutic Toxicity, run by Xijing Hospital at 3 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 8 inclusion and 25 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: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse event (time frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days). 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 6 Jun 2025.