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

NCT04848597 | Unknown Phase 2

• 1 other identifier: CUP-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Unknown Primary

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR) was assessed using RECIST1.1 and IRECIST standards.

  ORR is defined as CR+PR

  Approximately 24 months

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection

Interventions

Recombinant humanized anti-PD-1 monoclonal antibody injection DRUG

200mg , once every 3 weeks

Also known as: Albumin Paclitaxel, bevacizumab

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu, MD, PhD

CONTACT

64175590; xchu2009@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of medical oncology

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 19, 2021
• Study Start: May 13, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 3, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CN (1)