Locally Advanced Gastric CancerPhase 2NCT05524974
Clinical Study of Camrelizumab, Apatinib Mesylate and Nab-paclitaxel Combined With Oxplatin and S-1 in the Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Genotypes
A Phase 2 study testing Camrelizumab, Oxaliplatin and S1 in people with Locally Advanced Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes 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, Oxaliplatin and S1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Sep 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years, all sex；
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology；
- 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.；
- 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）;
- ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores;
- the expected survival time is more than 12 weeks;
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- the main organ function is normal, which should meet the following criteria: （1）(1)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； （2）biochemical examination shall comply with the following criteria：
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- 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）
- 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.；
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Efficacy of Carrelizumab, Apatinib Mesylate, Albumin Paclitaxel Combined With Oxaliplatin and S-1 in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Genotypes--A Prospective, Multi-center, Randomized Controlled Study
To evaluate the clinical efficacy of camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes
- Conditions
- Locally Advanced Gastric Cancer
- Being tested
- Camrelizumab, Oxaliplatin, S1, Apatinib Mesylate, Nab paclitaxel
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.
OxaliplatinDrug
Oxaliplatin for Injection 135mg/m2 /per day，ivgtt，in day1. Given once every 3 weeks.
S1Drug
S-1 was calculated according to body surface area , P.O., bid, d1-d14. And the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time
Apatinib MesylateDrug
Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday.
Nab paclitaxelDrug
nab-paclitaxel One course will last 21 days. Given twice every 3 weeks at a dose of 260 mg/m2 in day 1 and day 8.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes | Experimental | Not described Receives: Drug: Camrelizumab; Drug: Oxaliplatin; Drug: S1 |
| Oxplatin and S-1 for Immune Genotypes | Active comparator | Not described Receives: Drug: Oxaliplatin; Drug: S1 |
| Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: S1; Drug: Apatinib Mesylate |
| Oxplatin and S-1 for Mesenchymal Genotypes | Active comparator | Not described Receives: Drug: Oxaliplatin; Drug: S1 |
| Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: S1; Drug: Nab paclitaxel |
| Oxplatin and S-1 for Classic Genotypes | Active comparator | Not described Receives: Drug: Oxaliplatin; Drug: S1 |
| Oxplatin and S-1 for Metabolic Genotypes | Active comparator | Not described Receives: Drug: Oxaliplatin; Drug: S1 |
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 (8)
R0 resection rate
The surgical procedure was total or subtotal gastrectomy with 3 weeks after total neoadjuvant therapy.
Measured: 4 months
Disease control rate
Measured: 4 months
1-year and 3-year OS/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 posted1 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 203 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, phD, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524974
- Sponsor's protocol ID
- Arise-FJ-G006
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 1 Sep 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 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Carrelizumab, Apatinib Mesylate, Albumin Paclitaxel Combined With Oxaliplatin and S-1 in Neoadjuvant Treatment of Locally Advanced Gastric Cancer With Different Genotypes--A Prospective, Multi-center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05524974
- Acronym / sponsor ID
- Arise-FJ-G006
- Conditions
- Locally Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 1 Sep 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 camrelizumab, apatinib Mesylate and nab-paclitaxel combined with oxplatin and S-1 in the neoadjuvant treatment of locally advanced gastric cancer with different genotypes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes | Experimental | Drug: Camrelizumab, Drug: Oxaliplatin, Drug: S1 |
| Oxplatin and S-1 for Immune Genotypes | Active comparator | Drug: Oxaliplatin, Drug: S1 |
| Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes | Experimental | Drug: Oxaliplatin, Drug: S1, Drug: Apatinib Mesylate |
| Oxplatin and S-1 for Mesenchymal Genotypes | Active comparator | Drug: Oxaliplatin, Drug: S1 |
| Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes | Experimental | Drug: Oxaliplatin, Drug: S1, Drug: Nab paclitaxel |
| Oxplatin and S-1 for Classic Genotypes | Active comparator | Drug: Oxaliplatin, Drug: S1 |
| Oxplatin and S-1 for Metabolic Genotypes | Active comparator | Drug: Oxaliplatin, Drug: S1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age from 18 to 75 years, all sex；
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by histology or cytology；
- 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.；
- 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）;
- ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores;
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 | Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes |
| OxaliplatinOxaliplatin for Injection 135mg/m2 /per day，ivgtt，in day1. Given once every 3 weeks. | Drug | Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes, Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes, Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes, Oxplatin and S-1 for Classic Genotypes, Oxplatin and S-1 for Immune Genotypes, Oxplatin and S-1 for Mesenchymal Genotypes, Oxplatin and S-1 for Metabolic Genotypes |
| S1S-1 was calculated according to body surface area , P.O., bid, d1-d14. And the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time | Drug | Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes, Camrelizumab combined with Oxplatin and S-1 for Immune Genotypes, Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes, Oxplatin and S-1 for Classic Genotypes, Oxplatin and S-1 for Immune Genotypes, Oxplatin and S-1 for Mesenchymal Genotypes, Oxplatin and S-1 for Metabolic Genotypes |
| Apatinib MesylateApatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday. | Drug | Apatinib Mesylate combined with Oxplatin and S-1 for Mesenchymal Genotypes |
| Nab paclitaxelnab-paclitaxel One course will last 21 days. Given twice every 3 weeks at a dose of 260 mg/m2 in day 1 and day 8. | Drug | Nab-paclitaxel combined with Oxplatin and S-1 for Classic Genotypes |
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
8 secondary outcomes
R0 resection rate
Time frame: 4 months
Disease control rate
Time frame: 4 months
1-year and 3-year OS/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 1 Sep 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, phD principal investigator
Fujian Medical University Union Hospital
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 Camrelizumab, Oxaliplatin and S1 in people with Locally Advanced Gastric Cancer, run by Fujian Medical 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 17 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 1 Sep 2022. 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?
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, PhD (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 1 Sep 2022.