Using Toripalimab with reduced chemotherapy for HPV-related throat cancer
Induction Chemotherapy of Toripalimab With Docetaxel and Cisplatin Followed by De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
This study is testing if using a lower dose of chemotherapy along with the drug Toripalimab can help people with HPV-related throat cancer feel better while reducing side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | Toripalimab, chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04867330 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining the immune checkpoint inhibitor Toripalimab with induction chemotherapy for patients with HPV-positive oropharyngeal carcinoma. The approach aims to reduce treatment-related toxicities by employing a de-escalation strategy, which includes lower radiation doses and omitting concurrent chemotherapy after a favorable response to initial treatment. The study is particularly focused on understanding whether these modifications can maintain survival rates while improving patient tolerability. The research is conducted at Fudan University Shanghai Cancer Centre.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed HPV-positive oropharyngeal squamous cell carcinoma.
Not a fit: Patients with prior anti-tumor treatments or those with other malignant tumors 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 HPV-related oropharyngeal carcinoma.
How similar studies have performed: Previous studies have shown promising results with reduced-dose radiation in similar cancers, but this specific approach with Toripalimab is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Shanghai
- Fudan Universtiy Shanghai Cancer Centre — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chaosu Hu, MD
- Email: hucsu62@163.com
- Phone: +8618017312903
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.