Stage IV Gastric Cancer With MetastasisPhase 2NCT05441254
Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study
A Phase 2 study testing Camrelizumab; Nab-paclitaxel; S-1 in people with Stage IV Gastric Cancer With Metastasis, run by Zhongshan Hospital Xiamen University.
Trial summary
The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IV Gastric Cancer With Metastasis
- What is being tested?
- Camrelizumab; Nab-paclitaxel; S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18 years old ≤ age ≤ 75 years old, both male and female;
- 2.Pathology (including histology or cytology) confirmed gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por), and HER2- (HER2 Negative: IHC 0/1+ or IHC2+ but ISH negative);
- 3. Confirm the diagnosis of gastric cancer peritoneal metastasis by laparoscopy, laparotomy or imaging examination;
- 4. According to the RECIST1.1 standard, the patient has at least one target lesion with measurable diameter (the long diameter of the CT scan of the tumor lesion is ≥10mm, the short diameter of the CT scan of the lymph node lesion is ≥15mm, and the scan slice thickness is 5mm;)
- 5. The damage caused by the patient's other treatments has recovered, and the interval between receiving nitroso or mitomycin is ≥ 6 weeks; receiving other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed;
- 6. ECOG PS: 0-2;
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- 7.Expected survival ≥ 12 weeks;
- 8. The main organs function normally and meet the following criteria:
- Routine blood: (no blood transfusion within 14 days):
- HB≥100g/L,
- WBC≥3×109/L,
- ANC≥1.5×109/L,
- PLT≥100×109/L;
- Blood biochemistry:
- BIL <1.5ULN,
- ALT and AST <2.5ULN, GPT≤1.5×ULN,
- Serum Cr≤1ULN, endogenous creatinine clearance rate >60ml/min (Cockcroft-Gault formula),
- ALB≥30g/L;
- 9. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; for men, surgical sterilization or Agree to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the trial drug;
- 10. Not participating in other clinical studies before and during treatment;
- 11. The patients voluntarily joined the study, signed the informed consent to participate in the experimental treatment, and agreed to participate in the observational study, with good compliance and cooperation with follow-up;
- 12. Has a quantifiable CT-PCI score.
Who cannot join
- 1. Patients who have previously received treatment with albumin-paclitaxel, Sigio, and camrelizumab; or patients who have previously received other immunotherapy (including other clinical research drugs) within 5 half-lives from the first study drug;
- 2. Concomitant Difficulties in swallowing, complete or incomplete gastrointestinal obstruction, active bleeding in the gastrointestinal tract, perforation, etc., etc.;
- 3. Participating in other clinical studies within 1 month before enrollment and the toxicity has not recovered;
- 4. There are a large number of Patients with ascites requiring frequent drainage that interferes with normal treatment;
- 5. Suffering from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism , including but not limited to these diseases or syndromes); patients requiring no intervention in adulthood, except for vitiligo or cured childhood asthma/allergies; autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones ; Type I diabetes mellitus using stable doses of insulin;
- 6. A history of immunodeficiency, including HIV test positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
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- 7. Accompanied by severe heart, lung, liver and kidney diseases; neurological and mental diseases; jaundice or gastrointestinal obstruction and concomitant severe infection;
- 8. pregnant or breastfeeding women;
- 9. The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which can manifest as clinical symptoms, cerebral edema, spinal cord compression meningitis, leptomeningeal disease, and/or progressive growth. CNS metastases are adequately treated, and neurological symptoms can return to baseline levels at least 2 weeks before enrollment (residual signs or symptoms associated with CNS treatment can be enrolled in the study). In addition, patients must discontinue corticosteroids or receive ≤10 mg/d of stable or tapered doses of prednisone (or equivalent doses of other corticosteroids) at least 2 weeks prior to enrollment;
- 10. Patients with grade I or above coronary heart disease, arrhythmia (including QTc interval prolongation > 450 ms in men, > 470 ms in women) and cardiac insufficiency;
- 11. Patients with clear gastrointestinal bleeding tendency, including the following conditions: Patients with locally active ulcer lesions, fecal occult blood (++), and a history of melena and hematemesis within 2 months; patients with abnormal coagulation function (INR>1.5, APTT>1.5 ULN);
- 12. The patient has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) ) Clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still poorly controlled after clinical intervention;
- 13. History of interstitial lung disease (except radiation pneumonitis without hormone therapy), non-infectious pneumonia medical history;
- 14. Patients with positive urine protein (urinary protein test 2+ or above, or 24-hour urine protein quantification >1.0g);
- 15. Those who are allergic to the experimental drug or its excipients;
- 16. those who are considered unsuitable for inclusion by the researchers.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.
Read the detailed description
The incidence of gastric cancer in China is high. Although the guidelines have recommended standard first and second-line chemotherapy, the survival rate of patients with advanced gastric cancer with peritoneal metastasis is still low.Nab-paclitaxel is a taxane drug, because of its binding to albumin, it does not need pretreatment before infusion, which is convenient for infusion, and has great application prospects in the treatment of advanced gastric cancer. There are positive expectations regarding the safety and efficacy of the combination. With the deepening of the understanding of the body's immune system and the rapid development of biotechnology, immunotherapy has become an important means of tumor treatment, and occupies an increasingly important position in the comprehensive tumor treatment system. At the same time, a number of studies have confirmed that camrelizumab combined with chemotherapy has a better therapeutic effect in gastric cancer, and the safety is tolerable.
In summary, how to improve the short-term and long-term efficacy of gastric cancer with peritoneal metastasis, while improving patient tolerance as much as possible and reducing adverse reactions, is an urgent problem to be solved. The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Being tested
- Camrelizumab; Nab-paclitaxel; S-1
- Keywords
- Camrelizumab, Nab-paclitaxel, Peritoneal Metastasis, Intraperitoneal Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab; Nab-paclitaxel; S-1Drug
Also called Arm PD-1
Camrelizumab: 200 mg, intravenous infusion, d1, q3w;
Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w;
S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w;
The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Camrelizumab: 200 mg, intravenous infusion, d1, q3w;
Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w;
S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w; Receives: Drug: Camrelizumab; Nab-paclitaxel; S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS)
Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.
Measured: 24 months
Secondary outcomes (2)
Overall survival (OS)
Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Measured: 24 months
Peritoneal Cancer Index (PCI) assessed on preoperative CT (CT-PCI)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Gastric Cancer With MetastasisStudies of the same condition, open and under way.
- 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Li Xiao, Phd, Principal investigator, Zhongshan Hospital Affiliated to Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441254
- Sponsor's protocol ID
- 2022-0627
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 8 Jul 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05441254
- Acronym / sponsor ID
- 2022-0627
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Keywords
- Camrelizumab, Nab-paclitaxel, Peritoneal Metastasis, Intraperitoneal Infusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Jul 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.
The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.
Detailed description
The incidence of gastric cancer in China is high. Although the guidelines have recommended standard first and second-line chemotherapy, the survival rate of patients with advanced gastric cancer with peritoneal metastasis is still low.Nab-paclitaxel is a taxane drug, because of its binding to albumin, it does not need pretreatment before infusion, which is convenient for infusion, and has great application prospects in the treatment of advanced gastric cancer. There are positive expectations regarding the safety and efficacy of the combination. With the deepening of the understanding of the body's immune system and the rapid development of biotechnology, immunotherapy has become an important means of tumor treatment, and occupies an increasingly important position in the comprehensive tumor treatment system. At the same time, a number of studies have confirmed that camrelizumab combined with chemotherapy has a better therapeutic effect in gastric cancer, and the safety is tolerable.
In summary, how to improve the short-term and long-term efficacy of gastric cancer with peritoneal metastasis, while improving patient tolerance as much as possible and reducing adverse reactions, is an urgent problem to be solved. The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Camrelizumab; Nab-paclitaxel; S-1Camrelizumab: 200 mg, intravenous infusion, d1, q3w; Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w; S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 1. Age: 18 years old ≤ age ≤ 75 years old, both male and female;
- 2.Pathology (including histology or cytology) confirmed gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por), and HER2- (HER2 Negative: IHC 0/1+ or IHC2+ but ISH negative);
- 3. Confirm the diagnosis of gastric cancer peritoneal metastasis by laparoscopy, laparotomy or imaging examination;
- 4. According to the RECIST1.1 standard, the patient has at least one target lesion with measurable diameter (the long diameter of the CT scan of the tumor lesion is ≥10mm, the short diameter of the CT scan of the lymph node lesion is ≥15mm, and the scan slice thickness is 5mm;)
- 5. The damage caused by the patient's other treatments has recovered, and the interval between receiving nitroso or mitomycin is ≥ 6 weeks; receiving other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed;
Key exclusion criteria (16 listed)
- 1. Patients who have previously received treatment with albumin-paclitaxel, Sigio, and camrelizumab; or patients who have previously received other immunotherapy (including other clinical research drugs) within 5 half-lives from the first study drug;
- 2. Concomitant Difficulties in swallowing, complete or incomplete gastrointestinal obstruction, active bleeding in the gastrointestinal tract, perforation, etc., etc.;
- 3. Participating in other clinical studies within 1 month before enrollment and the toxicity has not recovered;
- 4. There are a large number of Patients with ascites requiring frequent drainage that interferes with normal treatment;
- 5. Suffering from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism , including but not limited to these diseases or syndromes); patients requiring no intervention in adulthood, except for vitiligo or cured childhood asthma/allergies; autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones ; Type I diabetes mellitus using stable doses of insulin;
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 |
|---|---|---|
| Camrelizumab; Nab-paclitaxel; S-1Also: Arm PD-1Camrelizumab: 200 mg, intravenous infusion, d1, q3w; Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w; S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w; The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment. | Drug | Experimental group |
Primary outcome
Progression Free Survival(PFS)
Time frame: 24 months
Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.
2 secondary outcomes
Overall survival (OS)
Time frame: 24 months
Peritoneal Cancer Index (PCI) assessed on preoperative CT (CT-PCI)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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. This study is not recruiting at the moment.
Li Xiao, Phd principal investigator
Zhongshan Hospital Affiliated to Xiamen University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab; Nab-paclitaxel; S-1 in people with Stage IV Gastric Cancer With Metastasis, run by Zhongshan Hospital Xiamen University.
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 22 inclusion and 16 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 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Xiao, Phd (13906036392, xiaolibohan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival(PFS) (time frame: 24 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 Jul 2022.