NCT06170710 Postoperative CCRT Followed by Immunotherapy in High-Risk LA HNSCC
| NCT ID | NCT06170710 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 173 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 173 participants in total. It began in 2023-12-01 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC).
Eligibility 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
Contact & Investigator
Jingbo Wang, Dr.
PRINCIPAL INVESTIGATOR
National Cancer Cencer/Cancer hospital
Frequently Asked Questions
Who can join the NCT06170710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06170710 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06170710 currently recruiting?
Yes, NCT06170710 is actively recruiting participants. Contact the research team at wangjingbo201001@163.com for enrollment information.
Where is the NCT06170710 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06170710 clinical trial?
NCT06170710 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Jingbo Wang, Dr. at National Cancer Cencer/Cancer hospital. The trial plans to enroll 173 participants.