Mesothelioma
Conditions
Interventions
NA:Ipalolitovolimab injection: 5mg/kg, Q3W, intravenous injection
Lenvatinib = 60kg, 12mg, oral, once a day, should be taken at a fixed time every day, on an empty stomach or with food (refer to the drug instructions).
Sponsors
Zhejiang Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary participation and written informed consent. 2. Age: 18 years and over, male or female. 3. Patients with histologically or cytologically proven unresectable, recurrent or metastatic mesothelioma of the pleura, peritoneum, pericardium, and tunica vaginalis. 4. Disease progression or intolerance after previous first-line or higher systemic therapy. 5. According to RECIST 1.1 criteria, at least one measurable target lesion was present, and a measurable lesion defined a tumor unidiameter, with a LAD (longest diameter)>=10 mm; a lymph node SAD (shortest diameter)>=15 mm; and a tumor maximum diameter >=20 mm measured by conventional methods Spiral CT measurements were >=10 mm; measurable lesions should not have received previous local treatment such as radiotherapy; (target lesions located within previously treated areas can also be selected if progression is confirmed and if they meet RECIST1.1 criteria) . 6. ECOG PS score: 0-2; 7. Blood routine: absolute neutrophil count (ANC)>=1.5 * 10^9l(1500/mm^3) ; platelets >=75 * 10^9/L (100,000/mm^3) ; hemoglobin >=9 g/DL (90 g/L) . 8. Liver function: serum total bilirubin (BIL)=50% on cardiac function test. 11. No severe complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal, obstruction, non-cancerous fever > 38 °C. 12. Those with good compliance were expected to follow up the efficacy and adverse reactions according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who had used immune checkpoint inhibitors in the previous 6 months; 2. Severe active infections, such as severe pneumonia requiring hospitalization, bacteremia, and infectious comorbidities, that occurred within 4 weeks before the first administration of study drug (CTCAE greater than Grade 2) ; Baseline Chest Imaging suggested the presence of active pulmonary inflammation, the presence of signs and symptoms of infection within 2 weeks prior to the first use of study drug, or the need for oral or intravenous antibiotic therapy, as well as the presence of pulmonary inflammation, exclusion of prophylactic use of antibiotics; 3. History of gastrointestinal perforation and/or fistula within 6 months before first dose; 4. The presence of uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 5. Patients with a history of active tuberculosis infection by medical history or CT examination, or a history of active tuberculosis infection within 1 year before enrollment, or more than 1 year before enrollment, were included, patients with a history of active tuberculosis infection but no formal treatment; 6. Any other malignancy diagnosed within 3 years before first use of study drug, except for those with a low risk of metastasis and death (5-year survival > 90%) , if the fully treated basal cell or squamous cell skin cancer or, except cervical carcinoma in situ; 7. Patients with previous or current heart disease classified as Grade 2 or above by the New York Heart Association; 8. Patients with definite bleeding tendency included: those with local active ulcer foci, occult blood in stool (+ +) , black stool and hematemesis within 2 months, and medical history; 9. Imaging findings showed that the tumor had invaded important blood vessels or, in the opinion of the investigators, had a high probability of fatal hemorrhage during treatment 10. Patients with central nervous system disease or symptomatic central nervous system metastases. 11. Patients with previous contraindications to immunotherapy (patients with immunodeficient disease) . For example, a history of underlying diseases of the immune system, including some active infections, poor baseline liver or renal function, or poor cardiac function; 12. Patients with known hypersensitivity, high sensitivity, or intolerance to study-related drugs or their excipients; 13. Pregnant or lactating women; 14. At the discretion of the investigators, the subjects had other factors that might have led them to be forced to discontinue the study, such as having other serious medical conditions (including mental illness) requiring co-treatment, severe abnormalities in laboratory values, and other medical conditions, family or social factors may have influenced the data collection of the subjects; 15. Those considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;overall survival;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactMeiyu Fang
Zhejiang Tumor Hospital
Outcome results
None listed