Combining chemotherapy and immunotherapy for high-risk head and neck cancer patients after surgery
Postoperative Concurrent Chemoradiotherapy Followed by Anti-PD-1 Antibody Maintenance Therapy in High-Risk Locally Advanced Head and Neck Squamous Cell Carcinoma
PHASE2 · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06170710
This study is testing if adding a new immune treatment to standard chemotherapy after surgery can help high-risk head and neck cancer patients stay cancer-free longer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 173 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06170710 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the effectiveness of adding an anti-PD-1 antibody to postoperative chemoradiotherapy in improving disease-free survival for patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC). The study will enroll 173 patients who have undergone surgery for their cancer and will randomly assign them to receive either standard chemoradiotherapy or chemoradiotherapy plus the PD-1 antibody. The goal is to determine if the combination treatment is more effective than chemoradiotherapy alone in preventing cancer recurrence.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed high-risk locally advanced head and neck squamous cell carcinoma who meet specific eligibility criteria.
Not a fit: Patients with low-risk head and neck cancer or those who cannot tolerate immunotherapy or chemoradiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with high-risk head and neck cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemoradiotherapy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven squamous cell carcinoma of the head and neck which include but not limit following primary sites: oral cavity, oropharynx, hypopharynx or larynx * Patients eligible with one or more High-Risk factors of the following: For HPV+ OPSCC: T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin\<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion；For HPV- HNSCC：T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin\<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion OR IV/V cervical lymph node metastases * ECOG performance score 0-1 * PD-L1 expression with CPS\>1 * No contraindications to immunotherapy or chemoradiotherapy * Adequate organ function * Female subject of childbearing potential should have a negative pregnancy test within 7 days prior to receiving the first dose of study medication.Female subjects of childbearing potential must be willing to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication. * Reproductive male subjects must agree to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication. * Informed consent is obtainable. Exclusion Criteria: * Previous or co-existing malignancies, except cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer * Active infection * Known active viral infection Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV * Active and/or historical autoimmune disease, except patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood * Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication * Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study * History of PD-1/L1 treatment * If the subjects underwent major surgery for non-tumors, the toxicity and complications of the surgery needed to be adequately treated and the body conditions returned to normal * Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment * Other circumstances leading to the termination of the study, as determined by the investigator
Where this trial is running
Beijing, Beijing Municipality
- National Cancer Cencer/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Jingbo Wang, Dr. — National Cancer Cencer/Cancer hospital
- Study coordinator: Jingbo Wang, Dr.
- Email: wangjingbo201001@163.com
- Phone: +861087787249
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.
Conditions: Head and Neck Squamous Cell Carcinoma