Neoadjuvant treatment for head and neck cancer using Camrelizumab and Dalpiciclib

The Safety and Feasibility of Neoadjuvant Camrelizumab With Dalpiciclib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma：A Phase 1 Trial

This study is testing a new combination of two drugs, Camrelizumab and Dalpiciclib, to see if it can help people with early-stage head and neck cancer do better before surgery.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: Camrelizumab, immunotherapy, chemotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06109207 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and feasibility of combining Camrelizumab, an anti-PD-1 immunotherapy, with Dalpiciclib, a CDK4/6 inhibitor, as a neoadjuvant treatment for patients with resectable head and neck squamous cell carcinoma (HNSCC). The trial aims to improve outcomes for patients who are newly diagnosed and have not developed distant metastasis. By utilizing this combination therapy, the study seeks to enhance the efficacy of neoadjuvant treatment, potentially leading to better surgical outcomes and overall survival rates. Participants will receive the treatment prior to surgery, with the goal of assessing both safety and therapeutic effectiveness.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed, surgically resectable HNSCC who have not developed distant metastasis.

Not a fit: Patients with a history of other malignancies or those with distant metastasis at diagnosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for patients with head and neck squamous cell carcinoma.

How similar studies have performed: While there have been several studies exploring the combination of immunotherapy and targeted therapies in HNSCC, this specific combination of Camrelizumab and Dalpiciclib is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age 18 years or above.
* Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following conditions:

  * were newly diagnosed and without distant metastasis;
  * were deemed surgically resectable evaluated by a head and neck surgeon;
  * were willing to undergo surgery.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Adequate organ and bone marrow function: absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L;ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN;albumin≥ 2.8 g/dL；creatinine clearance ≥ 60 ml/min；INR≤ 1.5；APTT≤ 1.5×ULN
* Written informed consent.

Exclusion Criteria:

* History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
* Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
* Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
* Any of prior therapy with:anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs； antitumor vaccine; any active vaccine against an infectious disease within 4 weeks prior to the first dose or planned during the study period; major surgery or serious trauma within 4 weeks before the first dose; toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 ·Grade 1 or the level specified by the inclusion/exclusion criteria.
* With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction \< 50%, etc.
* With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
* With hyperthyroidism, or organic thyroid disease.
* With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
* With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
* History of a clear neurological or psychiatric disorder.
* History of drug abuse or alcohol abuse.
* Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures.
* Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
* Any other factors that are not suitable for inclusion in this study judged by investigators.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Jin Zhou, MD.,PhD. — West China Hospital
• Study coordinator: Jin Zhou, MD.,PhD.

Conditions: Head and Neck Squamous Cell Carcinoma, Neoadjuvant therapy, Immunotherapy, CDK4/6 inhibitor