Induction chemotherapy with PD-1 inhibitors for oropharyngeal cancer
Selective De-escalation of Radiotherapy Density Based on Response to Induction Chemotherapy With PD-1 Inhibitor Toripalimab, Docetaxel, Cisplatin, and Capecitabine in Locally Advanced Oropharyngeal Carcinoma: A Prospective Phase II Trial (DEDICATE-1)
This study is testing a new treatment approach that combines PD-1 inhibitors with chemotherapy for people with HPV-positive oropharyngeal cancer to see if it can reduce side effects while still being effective.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | Toripalimab, chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06156891 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of PD-1 inhibitors combined with induction chemotherapy for patients with oropharyngeal cancer, particularly focusing on those with HPV-positive tumors. The approach aims to reduce treatment toxicity while maintaining effective outcomes by utilizing a de-escalation protocol after initial chemotherapy. The study will assess the efficacy of this method in improving patient responses and minimizing side effects compared to conventional treatments. Participants will be closely monitored for their response to the induction therapy before determining the intensity of subsequent treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histological diagnosis of squamous cell carcinoma of the oropharynx, either HPV-positive or negative, and specific staging criteria.
Not a fit: Patients with prior anti-tumor treatments, severe organ dysfunction, or uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less toxic treatment options for patients with oropharyngeal cancer while maintaining effective cancer control.
How similar studies have performed: Previous studies have shown promising results in reducing treatment toxicity for HPV-related oropharyngeal cancer, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Histological diagnosis of squamous cell carcinoma of oropharynx; IHC p16 positive or PCR HPV16 positive; IHC p16 negative or PCR HPV16 negative; T3-4N0-3M0 or T1-2N2-3M0 according to UICC/AJCC 8th staging system; Age ≥18; No prior anti-tumor treatment; Informed consent obtained; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Normal complete blood count; Normal hepatic function; Normal renal function (creatinine ≤ 1.5 times the upper limit of normal). - Exclusion Criteria: Previous radiotherapy; A history of any other type of malignancy; Pregnancy or lactation; Obvious disfunction of liver, renal, cardiac or lung function; Un controlled infection; Systemic metastasis or distant metastasis; Patients with severe gastrointestinal diseases; Patients with mental disorders affecting patient participation in trial judgement. -
Where this trial is running
Shanghai, Shanghai
- Eye & ENT Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Xiaoshen Wang, MD, Ph.D
- Email: xiaoshen.wang@fdeent.org
- Phone: 18917785187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.