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

NCT ID: NCT04848597

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2023-05-03

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.

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.

Conditions

Cancer of Unknown Primary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

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

Group Type: EXPERIMENTAL

Recombinant humanized anti-PD-1 monoclonal antibody injection

Intervention Type: DRUG

200mg , once every 3 weeks

Interventions

Recombinant humanized anti-PD-1 monoclonal antibody injection

200mg , once every 3 weeks

Intervention Type: DRUG

Other Intervention Names

Albumin Paclitaxel; bevacizumab

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xichun Hu

Director of department of medical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xichun Hu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xichun Hu, MD, PhD

Role: CONTACT

xchu2009@hotmail.com

64175590 ext. 85006

Facility Contacts

Xichun Hu

Role: primary

xchu2009@hotmail.com

13816110335

Other Identifiers

CUP-002

Identifier Type: -

Identifier Source: org_study_id