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

Immune Checkpoint Inhibitor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867330
• Other study ID #: 2020-OR001
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: January 2026

Study information

• Verified date: April 2021
• Source: Fudan University
• Contact: Chaosu Hu, MD
• Phone: +8618017312903
• Email: hucsu62[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 2026
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• De-escalation
• Immune Checkpoint Inhibitor
• Oropharyngeal Carcinoma
• Oropharyngeal Neoplasms

Intervention

Other:
• Toxicities reduced treatment arm
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)

Locations

Country	Name	City	State
China	Fudan Universtiy Shanghai Cancer Centre	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS PFS	Progression Free Survival	2 year