Clinical trial · Interventional
A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck Cancer
A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable Head and Neck Squamous Cell Carcinoma
NCT04405154CI-TRIAL-00045281unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Biological | Camrelizumab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| IMRT or VMAT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Investigational Arm
- description
- Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.
- interventionNames
- Biological: Camrelizumab
- Drug: Cisplatin
- Radiation: IMRT or VMAT
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 6 months
- description
- The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1
Secondary outcomes (3)
- measure
- Overall Survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Has a pathologically proven new diagnosis of head and neck squamous cell carcinoma * Has unresectable disease and is eligible for definitive chemoradiation based on investigator decision * Has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) based on RECIST version 1.1 * Has adequate organ function as defined * Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy * Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy Exclusion Criteria: * Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer * Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy * Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization * Has a history of severe hypersensitivity reaction to camrelizumab, Cisplatin or radiotherapy * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy * Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or has previously participated in clinical studies with camrelizumab * Has received a live vaccine within 30 days prior to the first dose of study therapy * Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study * Has not recovered from major surgery prior to starting study therapy * Has known active Hepatitis B or C * Has known history of Human Immunodeficiency Virus (HIV) * Has a significant cardiovascular disease * Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment * Has had previous allogeneic tissue/solid organ transplant * Has active infection requiring systemic therapy * Is pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.