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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04848597
Other study ID # CUP-002
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 13, 2021
Est. completion date May 3, 2023

Study information

Verified date April 2022
Source Fudan University
Contact Xichun Hu, MD, PhD
Phone 64175590
Email xchu2009@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date May 3, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Recombinant humanized anti-PD-1 monoclonal antibody injection
200mg , once every 3 weeks

Locations

Country Name City State
China Fudan University Shanghai Cancer Center Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary objective response rate (ORR) was assessed using RECIST1.1 and IRECIST standards. ORR is defined as CR+PR Approximately 24 months
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