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

NCT ID: NCT04867330

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oropharyngeal Carcinoma Immune Checkpoint Inhibitor De-escalation

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Toxicities reduced treatment arm

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Chaosu Hu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan Universtiy Shanghai Cancer Centre

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chaosu Hu, MD

Role: CONTACT

Phone: +8618017312903

Email: [email protected]

Facility Contacts

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Tingting xu, MD

Role: primary

Other Identifiers

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2020-OR001

Identifier Type: -

Identifier Source: org_study_id