Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Esophageal or Head and Neck Squamous Cell Carcinomas

• Status: Recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death protein 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC) or or head and neck squamous cell carcinoma(HNSCC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West China Hospital

Criteria

Inclusion Criteria:

1. Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies.

1.1. The primary tumor should be located in the thorax; the primary site is decided by the upper margin of the mass (upper thoracic esophagus: from the thoracic inlet to inferior margin of azygos arch, the endoscopic examination shows 20-25cm to the incisor; middle thoracic esophagus: from inferior margin of azygos arch to the inferior pulmonary vein level, the endoscopic examination shows 25-30cm to the incisor; lower thoracic esophagus: from the inferior pulmonary vein level to the stomach, the endoscopic examination shows 30-40cm to the incisor).

1.2. The patients should be evaluated to be able to have surgical resection before the surgery according to the examinations (use enhanced thoracic and abdominal CT, cervical lymph node ultrasound to evaluate whether the tumor has obvious invasion, whether there are enlarged mediastinal lymph nodes; use examinations including positron emission computed tomography (PET-CT), endoscopic ultrasonography (EUS) to make further clinical staging if considering the primary tumor as T4b, multiple mediastinal lymph nodes metastasis or distant metastasis).

1.3. The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.

1.4. The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.

2. Patient diagnosed with locally advanced head and neck squamous cell carcinoma confirmed by histology or cytology.

2.1. Patients who are recommended to perform surgery

2.2. Patients between 18 and 70 years old

2.3. ECOG: 0～2 points

2.4. Estimated survival time ≥ 6 months

2.5. The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.

Exclusion Criteria:

• 1.The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) which can not be resected according to imaging examinations like thoracic and abdominal enhanced CT, cervical lymph nodes ultrasound, whole body PET-CT scan (optional) or endobronchial ultrasonography (EBUS) (optional); several enlarged lymph nodes existed (≥3 estimated lymph nodes metastasis); multiple station enlarged lymph nodes existed (≥2 estimated stations of lymph nodes metastasis); distant metastasis existed.

2.The patients have accepted or are on the process of other chemotherapy, radiotherapy, targeted therapy or immunotherapy.

3.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.） 4. Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.

5. Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.

6.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.

7.With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.

8.The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy.

9.The patients have active infection of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) or be HIV serum positive; or HBV, HCV RNA positive.

10.Female who is positive for serum pregnancy test or during lactation period, or people at child bearing stage who are reluctant to use contraception measures during the research.

11.History of a clear neurological or psychiatric disorder.

12.History of a clear neurological or psychiatric disorder.

13.Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.

14.Any other factors that are not suitable for inclusion in this study judged by investigators.