PD-1 Inhibitor and Nab-paclitaxel and Bevacizumab in CUP

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2, Open-label, Single Center, Prospective Study of Recombinant Humanized Anti-PD-1 Monoclonal Antibody Combined With Nab-paclitaxel and Bevacizumab in the Second-line Treatment of Patients With Cancer of Unknown Primary (CUP)

Conditions
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Cancer of Unknown Primary

Intervention / Treatment
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* Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Recombinant humanized anti-PD-1 monoclonal antibody injection:200mg once every 3 weeks | Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection<br>* 200mg , once every 3 weeks<br>* Other names: bevacizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate (ORR) was assessed using RECIST1.1 and IRECIST standards. | ORR is defined as CR+PR | Approximately 24 months |