peritoneal metastatic carcinoma
Conditions
Interventions
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged >= 18 years; 2. Patients with secondary peritoneal carcinoma who are ineffective or do not tolerate standard therapy or lack effective treatment confirmed by laparoscopy, laparotomy or imaging; 3. The primary lesions were mainly gastric cancer, colorectal cancer, ovarian cancer and pancreatic cancer confirmed by histological; 4. Ascites were show by CT-scan; 5. The values of laboratory tests done for screening must meet the following criteria: (1) WBC >= 3.0 x 10^9/L; ANC >= 1.5 x 10^9/L; HB >= 90 g/L (Patients may receive blood transfusions to meet this criterion); PLT >= 75 x 10^9/L; (2) ALT and AST = 20 g/L; Serum creatinine 50 mL/min; TBIL = 50% by echocardiography; 6. Eastern Cooperative Oncology Group (ECOG) 0~2 points; 7. Estimated lifetime >= 3 months; 8. All participants and their partners who had no birth plan and agreed to use effective non-pharmacological contraception (e.g., condoms, unmedicated IUDs, etc.) during the trial period from screening to the end of the trial, or who had taken permanent contraception, such as bilateral tubal ligation, vasectomy, etc.; 9. Voluntarily participate in clinical studies and sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Patients with primary peritoneal carcinoma; 2. Other malignant tumors occurred within 5 years before enrollment, except for carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell carcinoma that had been treated for radical treatment before; 3. Symptomatic central nervous system metastasis; 4. Patients who receive excessively high doses of systemic corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressants within 2 weeks prior to first dose. Exceptions are given topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylaxis, such as contrast; 5. Those who have received other viral vector-related drugs within 28 days before the first dose, except for inactivated vaccines; 6. Have undergone any major surgery (other than laparotomy or laparoscopic exploratory surgery) or major trauma within 14 days prior to first use, or major surgery scheduled during DLT observation; within 2 weeks of the end of previous antineoplastic therapy (including chemological/radiotherapy, targeted therapy, immunotherapy, Chinese herbal therapy, endocrine therapy or other antineoplastic therapy) or within the five half-lives of the treated drug (whichever is shorter); within 4 weeks of the end of previous radiation therapy; 7. Those who have not recovered from adverse effects of previous treatment (treatment-related toxicity grade 38.5 °C (neoplastic febrile subjects are included in the study at investigator's discretion), symptomatic congestive heart failure according to NYHA cardiac function classification >= 3, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer disease, or gastritis; 15. Patients with severe hematopoietic dysfunction; 16. Those who have a history of severe chronic diseases or serious diseases of the system such as heart disease and cerebrovascular disease; 17. Known hypersensitivity to the study drug or its components; 18. Patients with prior organ transplantation; 19. Previous history of neuropathy or psychiatric disorder (including epilepsy or dementia); 20. Pregnant or lactating women; 21. Any reasons that the investigators believe that patients are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Maximal Tolerable Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Pharmacokinetics;immunogenicity;Objective Response Rate;volume of ascites; | — |
Countries
China
Contacts
Public ContactFunan Liu
The First Affiliated Hospital of China Medical University
Outcome results
None listed