search
Back to results

Toripalimab Based Induction Chemotherapy Followed by De-escalation Protocols in HPV-related OPSCC

Primary Purpose

Oropharyngeal Carcinoma, Immune Checkpoint Inhibitor, De-escalation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Toxicities reduced treatment arm
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16
  • positive or PCR HPV16 positive
  • T1-2/N1-3M0(except T1N1M0 and single LN<3cm)or T3-4N0-3M0 according to UICC/AJCC 8th staging system
  • Age ≥18
  • No prior anti-tumor treatment
  • Karnofsky Performance Score (KPS)≥70
  • Adequate blood supply
  • Informed consent obtained

Exclusion Criteria:

  • Cannot take contrast-MRI imaging
  • Pregnant
  • Combined with other malignant tumor (except basal cell carcinoma of skin)

Sites / Locations

  • Fudan Universtiy Shanghai Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

conventional treatment arm

Arm Description

Two cycles Toripalimab+docetaxel+cisplatin induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)

Outcomes

Primary Outcome Measures

PFS PFS
Progression Free Survival

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
April 27, 2021
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT04867330
Brief Title
Toripalimab Based Induction Chemotherapy Followed by De-escalation Protocols in HPV-related OPSCC
Official Title
Induction Chemotherapy of Toripalimab With Docetaxel and Cisplatin Followed by De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma (NPC), oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma. Immune checkpoint inhibitors (ICIs) have proved to improve outcomes of head and neck cancers including EBV-related NPC. Oropharyngeal carcinoma was considered to be similar with NPC in terms of immune environment. So we added anti-PD-1 antibody Toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Carcinoma, Immune Checkpoint Inhibitor, De-escalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional treatment arm
Arm Type
Experimental
Arm Description
Two cycles Toripalimab+docetaxel+cisplatin induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)
Intervention Type
Other
Intervention Name(s)
Toxicities reduced treatment arm
Intervention Description
Two cycles Toripalimab+docetaxel+cisplatin induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
Primary Outcome Measure Information:
Title
PFS PFS
Description
Progression Free Survival
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive T1-2/N1-3M0(except T1N1M0 and single LN<3cm)or T3-4N0-3M0 according to UICC/AJCC 8th staging system Age ≥18 No prior anti-tumor treatment Karnofsky Performance Score (KPS)≥70 Adequate blood supply Informed consent obtained Exclusion Criteria: Cannot take contrast-MRI imaging Pregnant Combined with other malignant tumor (except basal cell carcinoma of skin)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaosu Hu, MD
Phone
+8618017312903
Email
hucsu62@163.com
Facility Information:
Facility Name
Fudan Universtiy Shanghai Cancer Centre
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingting xu, MD
Phone
+8618017312903

12. IPD Sharing Statement

Learn more about this trial

Toripalimab Based Induction Chemotherapy Followed by De-escalation Protocols in HPV-related OPSCC

We'll reach out to this number within 24 hrs