Colorectal cancer
Conditions
Interventions
1:JS001
Sponsors
Fudan University Zhongshan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fully understand the study and sign informed consent voluntarily; 2. Histologically confirmed advanced or recurrent colorectal cancer, and MSI detection identified MSI-H; 3. Patients who have previously received first-line or above chemotherapy or targeted therapy and failed to the treatment or experienced recurrence; 4. At least one measurable lesion (RECIST 1.1); 5. Agree to provide tumor tissue samples and Pathology reports related to the specimens; 6. Aged 18 to 75 years, gender not limited; 7. ECOG PS 0-1; 8. Expected survival =3 months; 9. Laboratory test values must meet the following standards within 7 days before enrollment: a. neutrophils=1.5×10^9/L; b. Platelet=100×10^9/L; c. Hemoglobin×90g/L (without infusion of concentrated red blood cells within 2 weeks); d. International standardized ratio (INR) or prothrombin time (PT) or activated partial thrombin time (aPTT) =1.5×ULN; e. Creatinine=1.5×ULN and creatinine clearance=50 mL/min; f. Serum total bilirubin=1.5×ULN (subjects with gilbert syndrome are allowed total bilirubin 3 ULN); g. AST and ALT=2.5×ULN; ALT and AST=5×ULN in patients with liver cancer or liver metastasis; Alkaline phosphatase=3×ULN, patients with bone metastasis: alkaline phosphatase=5×ULN; 10. Within 21 days before enrollment, women of reproductive age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the study drug use and within 60 days after the last dose. Women of reproductive age in this program are defined as sexually mature women: a. have not undergone hysterectomy or bilateral oophorectomy; b. natural menopause does not last for 12 consecutive months (after cancer treatment, amenorrhea does not preclude fertility) (menstruation has occurred at any time during the previous 12 consecutive months).
Exclusion criteria
Exclusion criteria: 1. Uncontrolled or symptomatic hypercalcemia (>1.5mmol/L ionic calcium or calcium > 12mg /dL or corrected serum calcium >ULN); 2. Had major surgery or had not fully recovered from previous surgery within 4 weeks before enrollment; 3. Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI) before screening and imaging evaluation; If new asymptomatic CNS metastases are detected during screening scans, patients must undergo radiotherapy and/or surgery for CNS metastases. If all other criteria are met after treatment, no additional brain scans are required; Patients who have previously received treatment for cerebral or meningeal metastasis, if clinical stability has been maintained for at least 1 month, and have stopped systemic sex hormone therapy (dose of >10mg/ day prednisone or other therapeutic hormones) for more than 4 weeks can be included; 4. For spinal cord compression without radical surgery and/or radiotherapy, or for spinal cord compression previously diagnosed, no clinical evidence showed that the disease was stable 4 weeks before enrollment; 5. Uncontrolled tumor-related pain: patients requiring analgesic treatment must have a stable analgesic treatment scheme when entering the study; If there are symptomatic lesions suitable for palliative radiotherapy (such as bone metastasis or metastatic nerve invasion), treatment should be conducted before enrollment. The effect of radiotherapy has been recovered, and the shortest recovery period is not required. Asymptomatic metastatic lesions that may lead to dysfunction or intractable pain if they develop further (such as no epidural metastasis with spinal cord compression), if appropriate, should be treated topically prior to admission; 6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allow the patient to have a catheter indwelling; 7. Having a history of idiopathic pulmonary fibrosis, organic pneumonia (such as bronchiolitis obliterans), drug pneumonia, idiopathic pneumonia or active pneumonia found in the screening of chest CT scan; 8. Uncontrolled active infection, including but not limited to acute pneumonia; 9. Uncontrolled major seizures or superior vena cava syndrome; 10. Have or have had other malignant tumors at the same time; 11. The patient has any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary hypophysitis, nephritis, hyperthyroidism and hypothyroidism); Patients with vitiligo or who have had complete remission from childhood asthma and need no intervention after adulthood may be included; Patients with asthma requiring medical intervention with bronchodilators were excluded. 12. Liver diseases of known clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, fatty liver and hereditary liver diseases. Active viral hepatitis is defined as: hepatitis b virus (HBV) infection and HBV DNA=1000cps/ml; Or hepatitis c virus (HCV) infection; Patients with past hepatitis b virus (HBV) infection or cured HBV infection (defined as hepatitis b core antibody [HBcAb] positive and HBsAg negative) may participate in this study. HBV DNA testing (HBV DNA<1000cps/ml before enrollment); Patients with positive HCV antibody test results were included in this study only when the PCR test re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival;Duration of Response; | — |
Countries
China
Contacts
Public ContactJianmin Xu
Fudan University Zhongshan Hospital
Outcome results
None listed