Induction Chemotherapy of Toripalimab With Docetaxel and Cisplatin Followed by De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fudan Universtiy Shanghai Cancer Centre
RECRUITING
Shanghai
Contact Information
Primary
Chaosu Hu, MD
hucsu62@163.com
+8618017312903
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 46
Treatments
Experimental: conventional treatment arm
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)
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov