Locally Advanced Gastric CancerPhase 3NCT05610332
Clinical Efficacy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Immunotypes
A Phase 3 study testing Camrelizumab, Albumin Taxol and FLOT scheme in people with Locally Advanced Gastric Cancer, run by Fujian Medical University at 2 sites in China.
Trial summary
To evaluate the clinical efficacy of albumin paclitaxel combined with carelizumab and FLOT in the neoadjuvant treatment of locally advanced gastric cancer with different immune types Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric Cancer
- What is being tested?
- Camrelizumab, Albumin Taxol and FLOT scheme
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2022to 1 Nov 2027
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age from 18 to 75 years, all sex； 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology； 3. CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.； 4. Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter of lymph node≥15mm，scan slice thickness 5mm）; 5. ECOG(Eastern Cooperative Oncology Group) PS(Performance Status):0-1 scores; 6. The expected survival time is more than 12 weeks; 7. The main organ function is normal, which should meet the following criteria:
- blood routine examination standards should be met（no blood transfusion within 14 days）
- HB≥100g/L，
- WBC≥3×109/L
- ANC≥1.5×109/L，
- PLT≥100×109/L；
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- biochemical examination shall comply with the following criteria：
- BIL <1.5normal upper limit（ULN），
- ALT和AST<2.5ULN，GPT≤1.5×ULN；
- serum Cr≤1ULN，creatinine clearance rate>60ml/min（Cockcroft-Gault formula） 8. women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug.； 9. No other clinical studies were conducted before and during the treatment； participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
Who cannot join
- Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy
- Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for major abdominal surgery；
- Patients with metastasis；
- Having any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or cured childhood asthma/allergies who did not need any intervention in adulthood were excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes with stable doses of insulin；
- A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation；
- Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection；
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- Pregnant or lactating women；
- The blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg)；
- With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted between male > 450 ms, women > 470 ms) and cardiac insufficiency；
- Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;；
- Subjects have failed to control good cardiovascular clinical symptoms or disease, including but not limited to: such as: (1) the NYHA class II heart failure or above (2) unstable angina pectoris (3) MI occurred within 1 year (4) have clinical significance of supraventricular or ventricular arrhythmias without clinical intervention on or after clinical intervention is still poorly controlled；
- History of interstitial lung disease (except radiation pneumonia without hormone therapy), and history of non-infectious pneumonia；
- Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g)；
- A person who has previously been allergic to any component of the drug in this study； The researchers consider those who were not suitable for inclusion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Department of Gastric Surgery
Fuzhou, Fujian
About this study
Official title: Clinical Efficacy of Albumin Paclitaxel Plus Carrelizumab Versus FLOT in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Immunotypes--A Multi-center, Randomised, Open, Phase 3 Clinical Trial
To evaluate the clinical efficacy of albumin paclitaxel combined with carelizumab and FLOT in the neoadjuvant treatment of locally advanced gastric cancer with different immune types
Read the detailed description
Background: At present, there is still a lack of prospective data to systematically compare the clinical efficacy of different neoadjuvant therapies in patients with different genotypes. To explore the clinical efficacy and safety of albumin paclitaxel combined with carrelizumab compared with FLOT neoadjuvant therapy in patients with locally advanced gastric cancer of different immune types.
Methods: This study is a multi center prospective study. 216 patients with gastric adenocarcinoma were included in the study to explore the proportion of PD-L1 positive cells in tumor tissue, evaluate the expression of PD-L1, serum HBV DNA level or other biomarkers.
- Conditions
- Locally Advanced Gastric Cancer
- Being tested
- Camrelizumab, Albumin Taxol, FLOT scheme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg.
Albumin TaxolDrug
Albumin paclitaxel was administered intravenously (without pretreatment) for 30 min on the first day of each cycle
FLOT schemeDrug
Docetaxel 50mg/m2, ivgtt, d1; Oxaliplatin 85 mg/m2, ivgtt, d1; Calcium folinate 200mg/m2, ivgtt, d1; 5-fluorouracil 2600mg/m2, 24h civ, d1,
4 cycles before and after operation, q2w
| Study group | Role | What they receive |
|---|---|---|
| Immune activated experimental group | Experimental | Albumin paclitaxel 260mg/m2, ivgtt, d1, d8 Carrelizumab: 200mg, ivgtt, d1, q3w Receives: Drug: Camrelizumab; Drug: Albumin Taxol |
| Immune activated control group | Active comparator | Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d Receives: Drug: FLOT scheme |
| Immune silence experimental group | Experimental | Carrelizumab: 200mg, ivgtt, d1, q3w Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d Receives: Drug: Camrelizumab; Drug: FLOT scheme |
| Immunosilent control group | Active comparator | Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d Receives: Drug: FLOT scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
Measured: 4 months
Secondary outcomes (9)
R0 resection rate
The surgical procedure was total or subtotal gastrectomy with 3 weeks after total neoadjuvant therapy
Measured: 4 months
Disease control rate
Disease control rate
Measured: 4 months
1-year and 3-year OS
1-year and 3-year OS
Measured: 1 and 3 years
1-year and 3-year DFS
1-year and 3-year DFS
Measured: 1 and 3 years
Adverse event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: 3 years
Overall postoperative morbidity rates
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery
Measured: 30 days
30 days mortality rates
Defined as the event observed within 30 days after surgery
Measured: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course
Measured: 30 days
The prediction performance of Exosome contents (including proteins, nucleic acids)
Exosomes were isolated using a Backman Optima XPN-100 instrument. The exosomes morphology was characterized using a HT7700 transmission electron microscope (Hitachi, Co. Ltd., Japan). Fluorescent spectra were recorded using a F96 Pro fluorospectrophotometer (Shanghai Lengguang Technology). The concentration and size distribution of the exosomes were quantified using nanoparticle tracking analysis (NanoSight NS 300, Malvern Instrument). The obtained results were subjected to biostatistical analysis, such as heat map generation, ROC curve establishment, and confusion matrix.
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 posted9 Nov 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-Ming Huang, Ph.D., Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610332
- Sponsor's protocol ID
- Arise-FJ-G007
- Status last verified
- Nov 2022
- First submitted
- 6 Oct 2022
- Last updated
- 9 Nov 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Albumin Paclitaxel Plus Carrelizumab Versus FLOT in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Immunotypes--A Multi-center, Randomised, Open, Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT05610332
- Acronym / sponsor ID
- Arise-FJ-G007
- Conditions
- Locally Advanced Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 9 Nov 2022 (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 clinical efficacy of albumin paclitaxel combined with carelizumab and FLOT in the neoadjuvant treatment of locally advanced gastric cancer with different immune types
Detailed description
Background: At present, there is still a lack of prospective data to systematically compare the clinical efficacy of different neoadjuvant therapies in patients with different genotypes. To explore the clinical efficacy and safety of albumin paclitaxel combined with carrelizumab compared with FLOT neoadjuvant therapy in patients with locally advanced gastric cancer of different immune types.
Methods: This study is a multi center prospective study. 216 patients with gastric adenocarcinoma were included in the study to explore the proportion of PD-L1 positive cells in tumor tissue, evaluate the expression of PD-L1, serum HBV DNA level or other biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immune activated experimental group | Experimental | Drug: Camrelizumab, Drug: Albumin TaxolAlbumin paclitaxel 260mg/m2, ivgtt, d1, d8 Carrelizumab: 200mg, ivgtt, d1, q3w |
| Immune activated control group | Active comparator | Drug: FLOT schemeDocetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d |
| Immune silence experimental group | Experimental | Drug: Camrelizumab, Drug: FLOT schemeCarrelizumab: 200mg, ivgtt, d1, q3w Docetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d |
| Immunosilent control group | Active comparator | Drug: FLOT schemeDocetaxel 50mg/m2, ivgtt, d1, q14d; Oxaliplatin 85mg/m2, ivgtt, d1, q14d; Calcium folinate 200mg/m2, ivgtt, d1, q14d; 5-fluorouracil 2600mg/m2, 24h civ, d1, q14d |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Age from 18 to 75 years, all sex； 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology； 3. CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.； 4. Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter of lymph node≥15mm，scan slice thickness 5mm）; 5. ECOG(Eastern Cooperative Oncology Group) PS(Performance Status):0-1 scores; 6. The expected survival time is more than 12 weeks; 7. The main organ function is normal, which should meet the following criteria:
- blood routine examination standards should be met（no blood transfusion within 14 days）
- biochemical examination shall comply with the following criteria：
Key exclusion criteria (14 listed)
- Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy
- Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for major abdominal surgery；
- Patients with metastasis；
- Having any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or cured childhood asthma/allergies who did not need any intervention in adulthood were excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes with stable doses of insulin；
- A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation；
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 |
|---|---|---|
| CamrelizumabCamrelizumab One course will last 21 days. Given once every 3 weeks at a dose of 200 mg. | Drug | Immune activated experimental group, Immune silence experimental group |
| Albumin TaxolAlbumin paclitaxel was administered intravenously (without pretreatment) for 30 min on the first day of each cycle | Drug | Immune activated experimental group |
| FLOT schemeDocetaxel 50mg/m2, ivgtt, d1; Oxaliplatin 85 mg/m2, ivgtt, d1; Calcium folinate 200mg/m2, ivgtt, d1; 5-fluorouracil 2600mg/m2, 24h civ, d1, 4 cycles before and after operation, q2w | Drug | Immune activated control group, Immune silence experimental group, Immunosilent control group |
Primary outcome
Objective response rate
Time frame: 4 months
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST
9 secondary outcomes
R0 resection rate
Time frame: 4 months
Disease control rate
Time frame: 4 months
1-year and 3-year OS
Time frame: 1 and 3 years
1-year and 3-year DFS
Time frame: 1 and 3 years
Adverse event
Time frame: 3 years
Overall postoperative morbidity rates
Time frame: 30 days
30 days mortality rates
Time frame: 30 days
Duration of postoperative hospital stay
Time frame: 30 days
The prediction performance of Exosome contents (including proteins, nucleic acids)
Time frame: 3 years
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 9 Nov 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.
Chang-Ming Huang, Ph.D. principal investigator
Fujian Medical University Union Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Camrelizumab, Albumin Taxol and FLOT scheme in people with Locally Advanced Gastric Cancer, run by Fujian Medical University at 2 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 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: opening soon, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Chang-Ming Huang, Ph.D. (8613805069676, hcmlr2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 4 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 Nov 2022.