A Prospective, Single Arm, Single Center, Phase II Clinical Trial of Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell
Overview
- Phase
- Phase 2
- Intervention
- camrelizumab
- Conditions
- PFS
- Sponsor
- Fudan University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pathological complete response rate (pCR)
- Last Updated
- 5 years ago
Overview
Brief Summary
A prospective, single arm, single center, phase II clinical trial of neoadjuvant chemotherapy with camrelizumab in locally advanced esophageal squamous cell,to evaluate the progression free survival
Investigators
Jialei Wang
Principal Investigator
Fudan University
Eligibility Criteria
Inclusion Criteria
- •The age ranged from 18 to 75 years
- •Middle or lower thoracic esophageal carcinoma
- •Gastroscopy showed squamous cell carcinoma
- •The clinical stage was c-txn1-3m0
- •ECOG score was 0-1
- •Can eat semifluid
- •Weight loss less than 20% in 6 months
- •Sign the consent form before treatment
- •One week before enrollment, the organ function level reached the following standards:
- •Bone marrow function: hemoglobin ≥ 100g / L, WBC ≥ 4.0 \* 10 \^ 9 / L, neutrophil count ≥ 1.8 \* 10 \^ 9 / L, platelet count ≥ 100 \* 10 \^ 9 / L;
Exclusion Criteria
- •The pathological findings were complex squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc
- •He had a history of subtotal gastrectomy
- •Patients with secondary primary cancer at the same time
- •The patients with distant metastasis indicated by imaging before treatment
- •Except for skin basal cell carcinoma, skin squamous cell carcinoma and / or cervical carcinoma in situ after effective treatment
- •Patients who have received chemoradiotherapy in the past
- •There were signs of esophageal perforation
- •Pregnant women of childbearing age
- •The patient has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, etc.)
- •There are patients with the following active infectious diseases, including active pulmonary tuberculosis, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analysis method), and known human immunodeficiency virus (HIV) infection
Arms & Interventions
neoadjuvant chemotherapy with camrelizumab
paclitaxel and cisplatin Carilizumab 200 mg, every 3 weeks, 2 cycles. Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
Intervention: camrelizumab
neoadjuvant chemotherapy with camrelizumab
paclitaxel and cisplatin Carilizumab 200 mg, every 3 weeks, 2 cycles. Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
Intervention: Paclitaxel
neoadjuvant chemotherapy with camrelizumab
paclitaxel and cisplatin Carilizumab 200 mg, every 3 weeks, 2 cycles. Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
Intervention: Neoadjuvant Chemotherapy
Outcomes
Primary Outcomes
Pathological complete response rate (pCR)
Time Frame: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)
Pathological complete response rate