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

NCT04867330 | Unknown

• 1 other identifier: 2020-OR001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Carcinoma; Immune Checkpoint Inhibitor; De-escalation

Outcome Measures

Primary Outcomes (1)

• PFS PFS

  Progression Free Survival

  2 year

Study Arms (1)

conventional treatment arm

EXPERIMENTAL

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)

Other: Toxicities reduced treatment arm

Interventions

Toxicities reduced treatment arm OTHER

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)

conventional treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Centre

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Chaosu Hu, MD

CONTACT

+8618017312903; hucsu62@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: January 1, 2026
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

CN (1)