Status:
UNKNOWN
PD-1 Inhibitor and Nab-paclitaxel and Bevacizumab in CUP
Lead Sponsor:
Fudan University
Conditions:
Cancer of Unknown Primary
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
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, ...
Eligibility Criteria
Inclusion
- The histopathologically confirmed metastasis is adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, poorly differentiated malignant tumor or neuroendocrine carcinoma;
- 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;
- Measurable lesions (RECIST 1.1 criteria);
- 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;
- ECOG of 0-2;
- Life expectancy\>3 months;
- 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
- Patients who have previously been treated with albumin paclitaxel or bevacizumab or PD-1 monoclonal antibody;
- Received any experimental drugs or anti-tumor drugs within 4 weeks prior to enrollment;
- A history of other tumors in the past 5 years, except for cervix or basal cell carcinoma of the skin that has been cured;
- 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/Exclusion criteria may apply.
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04848597
Start Date
May 13 2021
End Date
May 3 2023
Last Update
April 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032