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
About this trial
This is an interventional treatment trial for Oropharyngeal Carcinoma
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)
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
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