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Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study

Primary Purpose

Metastatic Nasopharyngeal Carcinoma, Chemotherapy Effect

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab

About this trial

This is an interventional treatment trial for Metastatic Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients diagnosed with metastatic or recurrent nasopharyngeal carcinoma are not suitable for radical local treatment.
Previous failure of first-line platinum-containing chemotherapy (single drug or combination).
Previously diagnosed WHO classification type II or III by histological pathology.
At least one measurable lesion (according to RECIST1.1).
Age between 18 and 70.
Eastern Cooperative Oncology Group (ECOG) 0-1, and life expectation at least 3 months.
Enough blood test.
Participate voluntarily and sign the informed consent.

Exclusion Criteria:

Previously diagnosed WHO classification type I by histological pathology.
Previous use of bevacizumab.
Previous use of sorafenib, apatinib, sunitinib, amlotinib and other small molecule --vascular targeting drugs.
Previous treatment with PD-1 mmune checkpoint inhibitor.
Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding.
A history of interstitial pneumonia or other autoimmune diseases.
Sever infection.
Sever heart disease.
HIV infection.
Allogeneic organ transplantation
Malignancy other than nasopharyngeal carcinoma.
Pregnancy or breast feeding.
Received other test drugs.

Sites / Locations

Yanqun Xiang

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1 immune checkpoint inhibitor combined with bevacizumab

Arm Description

Outcomes

Primary Outcome Measures

objective response rate (ORR)

The proportion of patients whose tumors shrink by a certain amount and remain in place for a certain amount of time, including complete response (CR) and partial response (PR).

Secondary Outcome Measures

overall survival (OS)

Patients in clinical trials were randomized to the time of death from any cause

progression-free survival (PFS)

36/5000 The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause.

duration of response (DOR)

The time between the first assessment of a tumor as CR or PR and the first assessment of PD or death from any cause.

Full Information

NCT ID

NCT04872582

First Posted

May 2, 2021

Last Updated

February 21, 2023

Sponsor

XIANG YANQUN

1. Study Identification

Unique Protocol Identification Number

NCT04872582

Brief Title

Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study

Official Title

PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: A Single Center, Single Arm, Phase II Clinical Study.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 29, 2021 (Actual)

Primary Completion Date

January 4, 2023 (Actual)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

XIANG YANQUN

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.

Detailed Description

To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Nasopharyngeal Carcinoma, Chemotherapy Effect

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PD-1 immune checkpoint inhibitor combined with bevacizumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab

Other Intervention Name(s)

Sintilimab

Intervention Description

combined

Primary Outcome Measure Information:

Title

objective response rate (ORR)

Description

The proportion of patients whose tumors shrink by a certain amount and remain in place for a certain amount of time, including complete response (CR) and partial response (PR).

Time Frame

2 years

Secondary Outcome Measure Information:

Title

overall survival (OS)

Description

Patients in clinical trials were randomized to the time of death from any cause

Time Frame

2 years

Title

progression-free survival (PFS)

Description

36/5000 The time from the commencement of a randomized clinical trial to the progression of tumorigenesis (in any respect) or death from any cause.

Time Frame

2 years

Title

duration of response (DOR)

Description

The time between the first assessment of a tumor as CR or PR and the first assessment of PD or death from any cause.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment. Previous failure of first-line platinum-containing chemotherapy (single drug or combination). Previously diagnosed WHO classification type II or III by histological pathology. At least one measurable lesion (according to RECIST1.1). Age between 18 and 70. Eastern Cooperative Oncology Group (ECOG) 0-1, and life expectation at least 3 months. Enough blood test. Participate voluntarily and sign the informed consent. Exclusion Criteria: Previously diagnosed WHO classification type I by histological pathology. Prior exposure to anti-PD-1/PD-L1 antibodies plus anti-VEGF antibodies. Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding. A history of interstitial pneumonia or other autoimmune diseases. Sever infection. Sever heart disease. HIV infection. Allogeneic organ transplantation Malignancy other than nasopharyngeal carcinoma. Pregnancy or breast feeding. Received other test drugs.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanqun Xiang, Dr.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yanqun Xiang

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study

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