Gastric CancerPhase 2NCT05982301
Sintilimab Combined With Modified FLOT Regimen in the Treatment of Metastatic Gastric Cancer
A Phase 2 study testing Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FU in people with Gastric Cancer and Chemotherapy Effect, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, one-arm, single-center phase II study. The objective was to evaluate the efficacy and safety of domestic PD-1 antibody Sintilimab combined with modified FLOT regimen in the treatment of metastatic gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Chemotherapy Effect, Immune Checkpoint Inhibitor
- What is being tested?
- Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2023to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years and men or women
- With histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, local lesions that cannot be radically resected, or metastatic gastric cancer
- For treatment-naïve patients, or postoperative recurrence at least 6 months from the last adjuvant chemotherapy
- With Eastern Cooperative Oncology Group (ECOG) PS of 0-1
- With a life expectancy of more than 3 months
- Who obtain the following laboratory test data within 7 days (including the seventh day) prior to the study screening: neutrophil count of ≥1.5 × 10^9/L, platelet count of ≥100 × 10^9/L, hemoglobin level of ≥90 g/L, serum total bilirubin of ≤1.25 the upper limit of normal (ULN); ALT and AST levels of ≤2.5 × ULN (≤5 × ULN for patients with liver metastasis); serum creatinine level of ≤1.0 × ULN and creatinine clearance of ≥50 ml/min; International Normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN; If the subject is receiving anticoagulant therapy, PT should be within the prescribed anticoagulant range.
- With at least one extragastric measurable lesion (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria)
- Patients (or their legal representative/guardian) must sign an informed consent form indicating that they understand the purpose of the study, understand the procedures necessary for the study, and are willing to participate in the study.
Who cannot join
- Patients with history of other types of cancer in the last 3 years, except for cured cervical cancer or cutaneous basal cell carcinoma.
- Patients with symptomatic brain or leptomeningeal metastases (unless the patient has been treated for >2 months) who has a negative imaging result within 4 weeks before participating in the study and is stable disease at study entry.
- Patients with clinically significant gastrointestinal obstruction, gastrointestinal bleeding (defecate occult blood + + + and above) or perforation.
- Patients who have received PD-1, PD-L1 or PD- L2, CD137, CTLA-4 antibody therapy, or any other T cells stimulate or total checkpoint pathways for specific target antibody or drugs.
- Patients with active, or have a history and possible recurrence of autoimmune disease of the subjects (such as: Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as those who have received an organ transplant requiring immunosuppressive therapy). However, patients with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment within the last 2 years, or patients with hypothyroidism who required only thyroid hormone replacement therapy, and patients with type 1 diabetes who required only insulin replacement therapy could be enrolled.
- Patients now with interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung diseases, radiation pneumonia.
Show all 22Show fewer
- Patients who received any investigational drugs or antitumor drugs within 4 weeks prior to enrollment.
- Patients who received immunosuppressive drugs within 4 weeks, which does not include nasal, inhalation or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/ day of prednisone or equivalent doses of other corticosteroids), or short-term (not exceeding 7 days) use of corticosteroids for the prevention or treatment of non-autoimmune allergic diseases.
- Patients who received the live attenuated vaccine within 4 weeks before the first dose of study treatment. Note: Inactivated virus vaccines for injectable seasonal influenza are permitted for up to 4 weeks prior to initial administration; But live attenuated influenza vaccines are not allowed;
- Patients who received major surgery within 4 weeks before the first dose of study treatment(open chest, craniotomy or laparotomy) or expected during the research and treatment need to accept major surgery not associated with this study.
- Patients who infected with human immunodeficiency virus (HIV) disease (HIV antibody positive), or with other acquired, congenital immunodeficiency disease, or has a history of organ transplantation, or stem cell transplantation.
- Patients who have chronic active hepatitis B or active active hepatitis C. Hepatitis B virus carriers, stable after drug treatment of hepatitis B (DNA drop degree is not higher than 200 iu/mL or copy number < 1000 copies/mL) and has cured patients with hepatitis c (HCV RNA test negative) into the group.
- Patients with known active tuberculosis.
- Patients with severe infections before 4 weeks of fisrt dose of treatment, active infection which needs oral or intravenous antibiotic therapy before 4 weeks of fisrt dose of treatment.
- Patients with symptomatic congestive heart failure (New York heart association grade II - IV) or symptomatic or poorly controlled arrhythmia.
- Patiemts with uncontrolled arterial blood pressure with specification treatment (systolic blood pressure of greater than 160mmHg or diastolic blood pressure of greater than 100 mmHg).
- Patients who had any arterial thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months before the screening.
- Patinets with deep vein thrombosis, pulmonary embolism, or any other serious history of thromboembolism within 3 months (implantable venous infusion port source sex or catheter thrombosis, or superficial venous thrombosis were not regarded as a "severe" thromboembolism).
- Patients who have a history of neurological or psychiatric disorders, such as memory, epilepsy, dementia, compliance, or the peripheral nervous system disorder.
- alcohol dependence or 1-year history of drug or drug abuse.
- Pregnancy or lactation women; Those who are fertile but do not take adequate contraceptive measures;
- may lead to the following results of other acute or chronic diseases, mental illness or abnormal laboratory values: participated in or study drug dosage associated with an increased risk, or interfere with the interpretation of results, and according to the researcher's judgment does not conform the patient to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Weijian Guo, 64175590, guoweijian1@hotmail.com
About this study
Official title: PD-1 Antibody Sintilimab Combined With Modified FLOT Regimen in the Treatment of Metastatic Gastric Cancer: a Phase II Clinical Study
This is a prospective, one-arm, single-center phase II study. The objective was to evaluate the efficacy and safety of domestic PD-1 antibody Sintilimab combined with modified FLOT regimen in the treatment of metastatic gastric cancer. To compare the time of maintenance of treatment after induction of chemotherapy with sintilimab combined with modified FLOT regimen until the reapplication of induction regimen with or without the combination of sintilimab, and the time of secondary progression after signing informed consent until the reapplication of induction regimen with or without the combination of sintilimab.
Read the detailed description
This study set up two cohorts, Cohort A: patients with HER2-negative advanced gastric cancer, and planned to enroll 87 patients with initially treated advanced gastric cancer. Thirty patients with ORR of more than 70% were enrolled in the first stage and then further enrolled. Cohort B: advanced gastric cancer patients with HER2 positive initial treatment, the number of enrolled is not specified. Patients with initially treated advanced gastric cancer who meet the inclusion criteria will be enrolled in this study to receive Sintilimab combined with mFLOT regimen. Trastuzumab was given to Cohort B. The results were repeated every 2 weeks and evaluated every 6 weeks. The examination methods were consistent with those at baseline. Patients without disease progression were treated for a maximum of 6 cycles, then switched to oral capecitabine monotherapy combined with the sintilimab until disease progression, intolerable adverse reactions, patient death, or withdrawal of informed consent. If intolerability toxicity of albumin paclitaxel or oxaliplatin occurs within 6 cycles, maintenance is advanced to sintilimab combined with capecitabine monotherapy. Patients were randomly assigned to Cohort A1 and Cohort A2 after maintaining treatment progress. Cohort A1: Cohort 1 combined with mFLOT; Cohort A2: mFLOT program Therapy. The regimen was repeated every 2 weeks and tumor efficacy was evaluated every 3 treatment cycles. Patients without disease progression were treated for a maximum of 6 cycles before being switched to monotherapy S-1 oral with or without sintilimab until disease progression, intolerable adverse reactions, patient death, or withdrawal of informed consent. The treatment should start within 1 week after the signing of informed consent, and the time from the signing of informed consent to the first progress should be PFS1; The time from the signing of informed consent to the progress of induction program back to the second progress is PFS2. In this study, peripheral blood and tissue samples of patients will be collected to analyze the correlation between biomarkers (such as Micro-RNA, cytokine expression levels, etc.) and efficacy and prognosis. The expected time of enrollment was 48 months, and the patients were observed clinically until disease progression and death. (PFS2 equals PFS1 if the induction regimen is applied again after the first disease progression and the first efficacy evaluation is the disease progression)
- Being tested
- Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FU
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FUDrug
Also called Sintilimab+mFLOT
The study has only one arm. Sintilimab 200mg d1 ivgtt+paclitaxel-albumin 125mg/m2 d1 ivgtt+oxaliplatin 85mg/m2 d1 ivgtt+5-FU 2.4g/m2 civ46h, q2w.
| Study group | Role | What they receive |
|---|---|---|
| Nab-POF | Experimental | Sintilimab 200mg d1 ivgtt+paclitaxel-albumin 125mg/m2 d1 ivgtt+oxaliplatin 85mg/m2 d1 ivgtt+5-FU 2.4g/m2 civ46h, q2w. Receives: Drug: Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free survival 2, PFS2
From date of informed consent to time of secondary progression
Measured: From date of informed consent to time of secondary progression, assessed up to 60 months
Secondary outcomes (4)
Overall survival, OS
the period from the date of randomization to the date of death from any cause.
Measured: the period from the date of randomization to the date of death from any cause, assessed up to 60 months
Objective response rate
the proportion of patients whose tumor dcrease to a certain size and remained for a certain period of time, including those with complete response(CR) and partial response (PR).
Measured: Baseline, Every 6 weeks during the procedure, up to 1 year. After 1 year, every 3 months.
Progression-Free survival 1, PFS1
From date of informed consent to time of first progression
Measured: From date of informed consent to time of first progression, assessed up to 60 months.
After Effects
CTC AE Version 5.0 will be used to evaluate the clinical safety of the treatment in the study.
Measured: Baseline, Every cycle of treatment, until disease progression or death, whichever come first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start9 Feb 2023
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (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 Fudan UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
- Investigators
- WeiJian Guo, M.D.,Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982301
- Sponsor's protocol ID
- FDZL-PFMG
- Status last verified
- Aug 2023
- First submitted
- 19 May 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share IPD after the publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Antibody Sintilimab Combined With Modified FLOT Regimen in the Treatment of Metastatic Gastric Cancer: a Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05982301
- Acronym / sponsor ID
- FDZL-PFMG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Aug 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.
This is a prospective, one-arm, single-center phase II study. The objective was to evaluate the efficacy and safety of domestic PD-1 antibody Sintilimab combined with modified FLOT regimen in the treatment of metastatic gastric cancer. To compare the time of maintenance of treatment after induction of chemotherapy with sintilimab combined with modified FLOT regimen until the reapplication of induction regimen with or without the combination of sintilimab, and the time of secondary progression after signing informed consent until the reapplication of induction regimen with or without the combination of sintilimab.
Detailed description
This study set up two cohorts, Cohort A: patients with HER2-negative advanced gastric cancer, and planned to enroll 87 patients with initially treated advanced gastric cancer. Thirty patients with ORR of more than 70% were enrolled in the first stage and then further enrolled. Cohort B: advanced gastric cancer patients with HER2 positive initial treatment, the number of enrolled is not specified. Patients with initially treated advanced gastric cancer who meet the inclusion criteria will be enrolled in this study to receive Sintilimab combined with mFLOT regimen. Trastuzumab was given to Cohort B. The results were repeated every 2 weeks and evaluated every 6 weeks. The examination methods were consistent with those at baseline. Patients without disease progression were treated for a maximum of 6 cycles, then switched to oral capecitabine monotherapy combined with the sintilimab until disease progression, intolerable adverse reactions, patient death, or withdrawal of informed consent. If intolerability toxicity of albumin paclitaxel or oxaliplatin occurs within 6 cycles, maintenance is advanced to sintilimab combined with capecitabine monotherapy. Patients were randomly assigned to Cohort A1 and Cohort A2 after maintaining treatment progress. Cohort A1: Cohort 1 combined with mFLOT; Cohort A2: mFLOT program Therapy. The regimen was repeated every 2 weeks and tumor efficacy was evaluated every 3 treatment cycles. Patients without disease progression were treated for a maximum of 6 cycles before being switched to monotherapy S-1 oral with or without sintilimab until disease progression, intolerable adverse reactions, patient death, or withdrawal of informed consent. The treatment should start within 1 week after the signing of informed consent, and the time from the signing of informed consent to the first progress should be PFS1; The time from the signing of informed consent to the progress of induction program back to the second progress is PFS2. In this study, peripheral blood and tissue samples of patients will be collected to analyze the correlation between biomarkers (such as Micro-RNA, cytokine expression levels, etc.) and efficacy and prognosis. The expected time of enrollment was 48 months, and the patients were observed clinically until disease progression and death. (PFS2 equals PFS1 if the induction regimen is applied again after the first disease progression and the first efficacy evaluation is the disease progression)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-POF | Experimental | Drug: Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FUSintilimab 200mg d1 ivgtt+paclitaxel-albumin 125mg/m2 d1 ivgtt+oxaliplatin 85mg/m2 d1 ivgtt+5-FU 2.4g/m2 civ46h, q2w. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 years and men or women
- With histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, local lesions that cannot be radically resected, or metastatic gastric cancer
- For treatment-naïve patients, or postoperative recurrence at least 6 months from the last adjuvant chemotherapy
- With Eastern Cooperative Oncology Group (ECOG) PS of 0-1
- With a life expectancy of more than 3 months
Key exclusion criteria (22 listed)
- Patients with history of other types of cancer in the last 3 years, except for cured cervical cancer or cutaneous basal cell carcinoma.
- Patients with symptomatic brain or leptomeningeal metastases (unless the patient has been treated for >2 months) who has a negative imaging result within 4 weeks before participating in the study and is stable disease at study entry.
- Patients with clinically significant gastrointestinal obstruction, gastrointestinal bleeding (defecate occult blood + + + and above) or perforation.
- Patients who have received PD-1, PD-L1 or PD- L2, CD137, CTLA-4 antibody therapy, or any other T cells stimulate or total checkpoint pathways for specific target antibody or drugs.
- Patients with active, or have a history and possible recurrence of autoimmune disease of the subjects (such as: Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as those who have received an organ transplant requiring immunosuppressive therapy). However, patients with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment within the last 2 years, or patients with hypothyroidism who required only thyroid hormone replacement therapy, and patients with type 1 diabetes who required only insulin replacement therapy could be enrolled.
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 |
|---|---|---|
| Sintilimab, paclitaxel-albumin, oxaliplatin, 5-FUAlso: Sintilimab+mFLOTThe study has only one arm. Sintilimab 200mg d1 ivgtt+paclitaxel-albumin 125mg/m2 d1 ivgtt+oxaliplatin 85mg/m2 d1 ivgtt+5-FU 2.4g/m2 civ46h, q2w. | Drug | Nab-POF |
Primary outcome
Progression-Free survival 2, PFS2
Time frame: From date of informed consent to time of secondary progression, assessed up to 60 months
From date of informed consent to time of secondary progression
4 secondary outcomes
Overall survival, OS
Time frame: the period from the date of randomization to the date of death from any cause, assessed up to 60 months
Objective response rate
Time frame: Baseline, Every 6 weeks during the procedure, up to 1 year. After 1 year, every 3 months.
Progression-Free survival 1, PFS1
Time frame: From date of informed consent to time of first progression, assessed up to 60 months.
After Effects
Time frame: Baseline, Every cycle of treatment, until disease progression or death, whichever come first.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Yes. We plan to share IPD after the publication of the study.
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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.
WeiJian Guo, M.D.,Ph.D. principal investigator
Fudan University
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, paclitaxel-albumin, oxaliplatin, 5-FU in people with Gastric Cancer and Chemotherapy Effect, run by Fudan University 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 22 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 8 Aug 2023. 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 WeiJian Guo, M.D.,Ph.D. (64175590, guoweijian1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free survival 2, PFS2 (time frame: From date of informed consent to time of secondary progression, assessed up to 60 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 8 Aug 2023.