Neoadjuvant ChemotherapyPhase 2NCT06459921
Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
A Phase 2 study testing SOX+Sintilimab and FLOT+Sintilimab in people with Neoadjuvant Chemotherapy and Sintilimab, run by Xijing Hospital.
Trial summary
This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoadjuvant Chemotherapy, Sintilimab, Locally Advanced Gastric Cancer
- What is being tested?
- SOX+Sintilimab and FLOT+Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2028
- 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
- 1. Age >=18 years and <100 years.
- 2. Diagnosed with locally advanced gastric cancer.
- 3. Eastern Cooperative Oncology Group ECOG PS score 0-1.
- 4. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.
- 5. deficient mismatch repair identified by pathological detection.
Who cannot join
- 1. Locally advanced unable to resect or metastatic tumors.
- 2. Patients with recurrence of residual gastric cancer
- 3. Patients refusing surgical resection after preoperative chemotherapy therapy.
- 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. Patients with confirmed allergy to the study drug and/or its excipients.
- 6. Severe malnutrition and active autoimmune diseases.
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- 7. Pregnant or lactating women.
- 8. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.
- 9. Patients with acute infections requiring antibiotic treatment.
- 10. Patients with acute infections requiring antibiotic treatment.
- 11. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.
- 12. Positive test result for hepatitis B or hepatitis C virus.
- 13. Untreated central nervous system metastatic peripheral neuropathy (>grade 1).
- 14. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
- 15. Patients who are not expected to achieve R0 resection.
- 16. Weight loss greater than or equal to 20% within 4 weeks before the first dose.
- 17. Patients with multiple factors affecting oral medication.
- 18. Vaccination within 4 weeks prior to the first dose of study drug.
- 19. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
- 20. 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Neoadjuvant Sintilimab Puls FLOT Versus Sintilimab Puls SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.
- Being tested
- SOX+Sintilimab, FLOT+Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOX+SintilimabDrug
Patients would be allocated to the SOX+Sintilimab group.
FLOT+SintilimabDrug
Patients would be allocated to the FLOT+Sintilimab group.
| Study group | Role | What they receive |
|---|---|---|
| FLOT+Sintilimab | Active comparator | 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 OXA 85 mg/m² intravenous TXT 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Sintilimab: 200 mg every 3 weeks. Receives: Drug: FLOT+Sintilimab |
| SOX+Sintilimab | Experimental | 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. Sintilimab: 200 mg every 3 weeks. Receives: Drug: SOX+Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of radical (R0) resection after neoadjuvant therapy
efficacy of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer.
Measured: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
Secondary outcomes (2)
adverse event
adverse event caused by FLOT, SOX or Sintilimab 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
disease-free survival
from diagnosis to recurrence or death
Measured: From date of diagnosis until the first documented recurrence or death, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant ChemotherapyStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459921
- Sponsor's protocol ID
- loong-201
- Status last verified
- Apr 2024
- First submitted
- 11 Jun 2024
- Last updated
- 10 Oct 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neoadjuvant Sintilimab Puls FLOT Versus Sintilimab Puls SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06459921
- Acronym / sponsor ID
- loong-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 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.
This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLOT+Sintilimab | Active comparator | Drug: FLOT+SintilimabPatients 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 OXA 85 mg/m² intravenous TXT 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Sintilimab: 200 mg every 3 weeks. |
| SOX+Sintilimab | Experimental | Drug: SOX+SintilimabPatients 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. Sintilimab: 200 mg every 3 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Age >=18 years and <100 years.
- 2. Diagnosed with locally advanced gastric cancer.
- 3. Eastern Cooperative Oncology Group ECOG PS score 0-1.
- 4. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.
- 5. deficient mismatch repair identified by pathological detection.
Key exclusion criteria (20 listed)
- 1. Locally advanced unable to resect or metastatic tumors.
- 2. Patients with recurrence of residual gastric cancer
- 3. Patients refusing surgical resection after preoperative chemotherapy therapy.
- 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. Patients with confirmed allergy to the study drug and/or its excipients.
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 |
|---|---|---|
| SOX+SintilimabPatients would be allocated to the SOX+Sintilimab group. | Drug | SOX+Sintilimab |
| FLOT+SintilimabPatients would be allocated to the FLOT+Sintilimab group. | Drug | FLOT+Sintilimab |
Primary outcome
The rate of radical (R0) resection after neoadjuvant therapy
Time frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
efficacy of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer.
2 secondary outcomes
adverse event
Time frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
disease-free survival
Time frame: From date of diagnosis until the first documented recurrence or death, assessed up to 60 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 10 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOX+Sintilimab and FLOT+Sintilimab in people with Neoadjuvant Chemotherapy and Sintilimab, run by Xijing 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 5 inclusion and 20 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: opening soon, as of the sponsor's last update on 10 Oct 2024. 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?
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 Jipeng Li, Doctor (13991316190, jipeng1974@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of radical (R0) resection after neoadjuvant therapy (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 10 Oct 2024.