advanced gastric cancer and colorectal cancer
Conditions
Interventions
Nal-IRI group:Gastric cancer:
Scheme 1: Irinotecan hydrochloride liposome injection: 28 mg/m2 (80--105% of the total dose) intravenous infusion for 90 minutes, days 1 and 5
14-day cycle
Scheme 2: (second-line and third-line patients Poor physical condition, single drug recommended) Paclitaxel for injection (albumin-bound): 75 mg/m2 (80--105% of the total dose) Intravenous infusion, d
Irinotecan hydrochloride liposome injection: 28 mg/m2 (80-105% of the total dose) Intravenous infusion 90 minutes, days 2 and 6
Colorectal cancer:
hydrochloric acid Irinotecan liposome injection: 28 mg/m2 (80--105% of the total dose) intravenously infused for 90 minutes, days 1 and 5
Fruquintinib: 5 mg orally, 1/day, day 1-10, 14-day cycle.
Sponsors
The First Affiliated Hospital of USTC
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) The patient has good compliance, can understand the research process of this study, and signs a written informed consent form; (2) Age >= 18 years old; (3) Gastric cancer/colorectal cancer confirmed by histopathology or cytopathology Patients; (4) Gastric cancer patients who have failed first-line treatment in the past or colorectal cancer patients who have failed second-line treatment in the past (relapse within 6 months after the end of adjuvant chemotherapy is considered a first-line treatment failure, and the previous irinotecan treatment has been in remission for more than 6 months) moon); (5) The nutritional status is rated B or C (using the PG-SGA nutritional assessment scale); (6) The expected survival period must be greater than 12 weeks; (7) According to RECIST1.1 standards, the patient has at least one evaluable lesion ; (8)KPS score >=50 points or ECOG score = 70g/L; absolute neutrophil count (ANC) >= 1.5×10^9/L; platelets (PLT) >= 90×10^9/L; (10) Liver function standards: ALT and AST <= 2.5 × upper limit of normal (ULN). If liver metastasis exists, ALT and AST <= 5 × ULN; serum total bilirubin < 1.5 × ULN; (11) Renal function standard: serum creatinine <=1.5 times the upper limit of normal; (12) HCV-RNA is lower than the lower limit of detection and HBV-DNA is less than 1×103 within 2 months before enrollment; (13) Not pregnant or breastfeeding Women of childbearing age; women/men of childbearing age should take effective contraceptive measures during the study period and within 6 months after the end of study treatment;.
Exclusion criteria
Exclusion criteria: (1) Patients who have suffered from other malignant tumors in the past 5 years (except cured carcinoma in situ and cutaneous basal cell carcinoma); (2) Patients with complete intestinal obstruction; (3) Concomitant use of potent CYP3A4 within 3 weeks before the first dose Inducers (see attachment for details), or patients who also use strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 3 weeks before the first dose; (4) Major organ surgery within 4 weeks before the first dose of the study drug (except needle biopsy, central venous catheterization, port catheterization, stent placement to relieve biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) Or patients with elective surgery plans; (5) There are contraindications for irinotecan hydrochloride liposome injection, such as allergies to the contained irinotecan or liposome components; (6) There are serious accompanying diseases: such as those with diabetes who cannot be well controlled by hypoglycemic drugs, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, acute gastrointestinal Moderate or massive bleeding, uncontrolled brain metastases, etc. during the period. For severe heart disease, the cardiac function classification needs to be evaluated and excluded according to specific circumstances; (7) If you currently or have had peripheral neuropathy of grade >= III in the past and have recovered to grade II or below, you can be enrolled if the researcher judges that there is no safety risk. Group ; (8) participated in other clinical studies within 4 weeks before enrollment; (9) received target lesion radiotherapy within half a year before enrollment; (10) used immune checkpoint inhibitors within 3 months before enrollment; (11) Patients who the researcher believes are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR,Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS,progression-free survival;OS,Overall survival;safety;quality of life; | — |
Countries
China
Contacts
Public ContactLi Suyi
The First Affiliated Hospital of USTC (West District)
Outcome results
None listed