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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer of Unknown Primary
• Intervention / Treatment: Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xichun Hu, MD, PhD; Phone Number: 85006 64175590; Email: xchu2009@hotmail.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Xichun Hu; Phone Number: 13816110335; Email: xchu2009@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Recombinant humanized anti-PD-1 monoclonal antibody injection:200mg once every 3 weeks	Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection; 200mg , once every 3 weeks; Other Names: bevacizumab; Albumin Paclitaxel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 3, 2023

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: CUP-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No