A Multi-center, Single-arm, Phase II Clinical Study of Camrelizumab in Combination With Albumin Paclitaxel and Cisplatin for Neoadjuvant Treatment of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- PD-1 inhibitor
- Conditions
- Head and Neck Cancer
- Sponsor
- Hunan Cancer Hospital
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Clinical remission rate(CRR)
- Last Updated
- 4 years ago
Overview
Brief Summary
In this single-arm study, pathologically confirmed advanced head and neck squamous cell carcinoma will be enrolled to investigate the efficacy and safety of Camrelizumab in combination With albumin paclitaxel and cisplatin.
Detailed Description
First, the patient received neoadjuvant therapy once every three weeks for a total of three cycles（Camrelizumab in combination With albumin paclitaxel and cisplatin）.After the neoadjuvant treatment, the patient undergoes surgery and postoperative radiotherapy.According to the surgical margin and postoperative pathological conditions, combined with cisplatin concurrent chemotherapy as appropriate.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-65 years, both men and women;
- •Patients who diagnosed as Squamous cell carcinoma by pathological examination;
- •Patients who have not received systemic or local treatment for head and neck squamous cell carcinoma;
- •The primary tumor and lymph nodes can be completely surgically removed;
- •Exclude distant metastasis through chest CT and full-body bone scanning;
- •The patient's vital organs are functioning normally and can tolerate the specified treatment plan Absolute neutrophil count ≥1.8 × 109 / L platelets ≥100 × 109/L, Hemoglobin ≥9g/dL, serum albumin ≥3g/dL Bilirubin≤1.5 ULN ALT and AST≤2.5 ULN INR≤1.5 ULN leukocyte≥2000/L Serum creatinine ≤ 1.5 ULN Thyroid Stimulating Hormone≤ 1 ULN
- •ECOG score：0-1
- •Women of childbearing age (15-49 years old) have a negative serum or urine HCG test within 7 days before treatment, and agree to use medically approved measures for contraception during treatment and 120 days after treatment ends
- •Males who have not been sterilized must agree to take effective contraceptive measures during the study period and at least 120 days after the last dose of PD-1 monoclonal antibody
- •Patients can provide enough tissue samples for PD-L1 detection or exploratory research.
Exclusion Criteria
- •Patients who pathologically confirmed non-squamous cell carcinoma
- •Patients who has recurrence or distant metastasis
- •Local lesions have been surgically removed
- •Patients who have received systemic anti-cancer therapy, including hormone therapy
- •Patients who have received treatment targeting PD-1 or PD-L1
- •Patients with active autoimmune disease or a history of autoimmune disease but may relapse(Patients with the following diseases are not excluded and can be further filtered)
- •Controlled type 1 diabetes
- •Hypothyroidism(If it can be controlled with hormone replacement therapy)
- •Controlled celiac disease
- •Skin diseases that do not require systemic treatment such as Vitiligo, Psoriasis and Hair loss.
Arms & Interventions
Camrelizumab，albumin paclitaxel and cisplatin.
Participants will be given intravenous administration of Camrelizumab (200mg)，Albumin Paclitaxel(260mg/m²) and Cisplatin（80mg/m²）,After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy. The duration of treatment will till death, or unacceptable toxicity show up.
Intervention: PD-1 inhibitor
Camrelizumab，albumin paclitaxel and cisplatin.
Participants will be given intravenous administration of Camrelizumab (200mg)，Albumin Paclitaxel(260mg/m²) and Cisplatin（80mg/m²）,After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy. The duration of treatment will till death, or unacceptable toxicity show up.
Intervention: Albumin Paclitaxel
Camrelizumab，albumin paclitaxel and cisplatin.
Participants will be given intravenous administration of Camrelizumab (200mg)，Albumin Paclitaxel(260mg/m²) and Cisplatin（80mg/m²）,After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy. The duration of treatment will till death, or unacceptable toxicity show up.
Intervention: Cisplatin
Outcomes
Primary Outcomes
Clinical remission rate(CRR)
Time Frame: immediately after the surgery
the short-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer
Pathological remission rate(PRR)
Time Frame: immediately after the surgery
the short-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer
Secondary Outcomes
- 2-year survival rate, 2-year progression-free survival rate, 2-year recurrence-free survival rate, 2-year survival rate without distant metastasis(2 year)
- Adverse event rate(2 year)