Cancer of Unknown Primary
Conditions
Brief summary
This trial is a single-center, prospective, single-arm Phase II clinical study. The purpose is to evaluate the efficacy and safety of recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab in the second-line treatment of patients with unknown primary tumors.
Detailed description
Recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab treatment, once every 3 weeks, treatment until disease progression, intolerable adverse reactions, patient death or withdrawal informed agree.After treatment, the patients was followed up every 9 weeks for follow-up treatment and survival.
Interventions
200mg , once every 3 weeks
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The histopathologically confirmed metastasis is adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, poorly differentiated malignant tumor or neuroendocrine carcinoma; 2. Patients whose primary lesions cannot be found after standard evaluation prior to treatment: detailed history, physical examination, blood test, chest and pelvic CT, PET/CT (optional), endoscopy of symptomatic sites, and pathological examination; 3. Measurable lesions (RECIST 1.1 criteria); 4. Patients who have progressed after receiving first-line treatment for Carcinoma of Unknown Primary. For example, those who have received paclitaxel or docetaxel in the first-line treatment and progressed more than three months after the end of last treatment; 5. ECOG of 0-2; 6. Life expectancy\>3 months; 7. Within 7 days (including 7 days) before screening, the laboratory test data requirements: neutrophil count ≥1.5×10\^9/L, platelet count ≥90×10\^9/L, hemoglobin ≥90g/L (No blood transfusion in 14 days), serum total bilirubin ≤1.25 times the upper limit of normal (ULN); ALT and AST≤2.5 x ULN (patients with liver metastases ≤5x ULN); serum creatinine ≤1.25 x ULN
Exclusion criteria
1. Patients who have previously been treated with albumin paclitaxel or bevacizumab or PD-1 monoclonal antibody; 2. Received any experimental drugs or anti-tumor drugs within 4 weeks prior to enrollment; 3. A history of other tumors in the past 5 years, except for cervix or basal cell carcinoma of the skin that has been cured; 4. Symptomatic brain or meningeal metastases (unless the patient receives treatment for\> 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms related to the tumor are stable at the time of entering the study). NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) was assessed using RECIST1.1 and IRECIST standards. | Approximately 24 months | ORR is defined as CR+PR |
Countries
China
Contacts
Primary ContactXichun Hu, MD, PhD
Outcome results
None listed