A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    20
  • sponsor
    RenJi Hospital
Updated on 25 January 2021

Summary

To evaluate the efficacy and safety of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Secondary study objective: To observe and evaluate the overall survival and adverse events of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). To evaluate the safety ofCamrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). Objective: To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer. To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer.

Details
Condition Gastric Cancer Stage III
Treatment docetaxel, S-1, Camrelizumab
Clinical Study IdentifierNCT04152889
SponsorRenJi Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Gastric Cancer Stage III?
Do you have any of these conditions: Do you have Gastric Cancer Stage III??
The patients voluntarily joined the study and signed the informed consent
18 years old, 80 years old, both male and female
Stage III gastric cancer confirmed by pathology
ECoG score: 0-1
Detection of biomarkers in postoperative gastric cancer samples suggests that: PD-L1 + CPS 10% / MSI-H + / EBV+/dMMR
No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment
During the study treatment period and within 3 months after the end of the study treatment period, a medically recognized contraceptive measure (such as IUD, contraceptive pill or condom) should be used for the female patients of non-surgical sterilization or childbearing age; the serum or urine HCG test of the female patients of non-surgical sterilization must be negative within 72 hours before the study group; and the hCG test must be non lactation; for the male patients Sex, should be surgical sterilization, or agree to use appropriate methods of contraception during the trial and within 3 months after the last administration of the test drug
The baseline blood routine and biochemical indexes of the selected patients should meet the following standards
hemoglobin 90g / L
absolute neutrophil count 1.5 10 ^ 9 / L
platelet count 100 10 ^ 9 / L
ASTor ALT 2.5 ULN
Alkaline phosphatase (ALP) 2.5ULN
TSH 1 ULN (if abnormal, T3 and T4 levels should be examined at the same time
if T3 and T4 levels are normal, they can be included in the group)

Exclusion Criteria

Pregnant or lactating women
Women of childbearing age were positive in the baseline pregnancy test
Distant metastasis was diagnosed by CT /MR/ EUS
Received previous anti-tumor treatment, including chemotherapy, radiotherapy or immunotherapy
Have other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer)
Uncontrollable pleural effusion, pericardial effusion or ascites
Severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure level II, uncontrolled arrhythmia and myocardial infarction within 12 months before admission
With gastroduodenal obstruction/bleeding, digestive dysfunction or malabsorption syndrome
Complicated with severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury
Allergic reaction to the drugs used in this study
Steroid or other systemic immunosuppressive therapy was used 14 days before admission
Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials)
Active autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected
History of primary immunodeficiency
Immunosuppressive drugs were used within 4 weeks prior to the first dose of study treatment, excluding local or physiological doses of systemic glucocorticoids (i.e. no more than 10mg / day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents
Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period
Active tuberculosis is known
We have known the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA 10 copies / ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time)
Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers. For example, serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, or other family or social factors, etc
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