Gastric cancer
Conditions
Interventions
Experimental group:Trifluridine and tipiracil hydrochloride tablets(TAS-102) + Oxaliplatin+ Sintilimab
Sponsors
Renji Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male or female patients, aged = 18 years old; 2) Imaging findings indicate unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma; 3) Confirmed by histology or cytology, the diagnosis is locally advanced unresectable or metastatic HER2 negative gastric or gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma); 4) The behavioral status score (ECOG PS) of the Eastern Cancer Collaborative Group is 0 or 1; 5) Having sufficient organ and bone marrow functions, defined as follows: ? ANC = 1.5 × 10 ^ 9/L; PLT = 90 × 10 ^ 9/L; Hb = 90 g/L; ? TBIL = 1.5 × ULN; ALT and AST = 2.5 × ULN, ALP = 2.5 × ULN; For patients with liver metastases, ALT and AST = 5 × ULN; ? BUN and Cr = 1.5 × ULN with creatinine clearance rate = 50 mL/min (Cockcroft Gault formula); ? LVEF = 50%; 6) The patient has at least one measurable lesion, which is evaluated by the researcher based on the efficacy evaluation criteria (RECIST) v1.1 for solid tumors; 7) Expected lifespan = 3 months; 8) Researchers evaluate that patients are able to comply with the protocol requirements; 9) Sign informed consent documents.
Exclusion criteria
Exclusion criteria: 1) Has undergone systemic cytotoxic drug chemotherapy due to advanced (metastatic) diseases; 2) Evidence suggests that disease progression occurs within 6 months after completion of neoadjuvant chemotherapy, adjuvant cytotoxic drug chemotherapy (or both), or radiotherapy for gastric cancer or gastroesophageal junction cancer; 3) Poor control over patients with drug allergies or hypersensitivity, as well as those with autoimmune diseases; Previously received allogeneic tissue/solid organ transplantation; 4) There is a third space effusion that cannot be controlled through drainage or other methods (such as a large amount of pleural and ascitic fluid); 5) Long term use of steroids with a dosage greater than 10mg per day is required; 6) Radiation therapy should be administered within 30 days prior to the use of the first dose of investigational drug (within 2 weeks, if palliative treatment is performed for peripheral bone metastasis and all toxicity is restored, it can be included in the study); 7) Uncontrolled symptomatic brain metastases or mental abnormalities that cannot accurately describe subjective symptoms; 8) According to the researchers, abnormal coagulation function has clinical significance; 9) At the same time, receive any other anti-tumor treatment, including anti-tumor traditional Chinese patent medicines and simple preparations and immune agents; 10) Unable to swallow, chronic diarrhea, and intestinal obstruction, there are multiple factors that affect medication administration and absorption; 11) Other malignant tumors (excluding GC) that occurred within the 5 years prior to enrollment, except for cervical carcinoma in situ or skin squamous or basal cell carcinoma that had previously been treated for curative purposes; 12) Pregnant or lactating women who have fertility but refuse to use contraceptive measures; 13) Individuals with a history of severe heart disease or illness, including: a documented history of congestive heart failure, uncontrolled heart rate abnormalities at high risk, angina requiring medication treatment, clinically confirmed valvular heart disease, a history of severe myocardial infarction, and refractory hypertension; 14) According to the investigator's judgment, there are concomitant diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study; 15) The researcher determined that other situations were not suitable for inclusion in the study. 16) Subjects with hypersensitivity reactions to the ingredients of the research drug, as well as peripheral neuropathy and functional impairment>level 1; 17) Have a history of immunodeficiency, including positive HIV testing; Acute or chronic active hepatitis B (defined as hepatitis B surface antigen HBsAg and/or hepatitis B core antibody positive (HBcAb) and hepatitis B virus DNA copy number 104 copies/mL or 2000 IU/mL) or acute or chronic active hepatitis C (HCVAb) positive HCV RNA 10^3 copies/mL. Subjects who have undergone nucleotides antiviral therapy and are below the above standards, as well as those who are HCV antibody positive but RNA test negative, are allowed to be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate, DCR;Overall survival, OS;Safety;Duration of response, DOR; | — |
Countries
China
Contacts
Public ContactXiaolin Lin
Renji Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed