Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell

NCT04520035 | Unknown Phase 2

• 1 other identifier: CAMRE-CHEM-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

PFS

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  Pathological complete response rate

  from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)

Study Arms (1)

neoadjuvant chemotherapy with camrelizumab

EXPERIMENTAL

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

Drug: camrelizumab; Drug: Paclitaxel; Drug: Neoadjuvant Chemotherapy

Interventions

camrelizumab DRUG

Carilizumab 200 mg, every 3 weeks, 2 cycles.Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles

Also known as: Paclitaxel, Cisplatin

neoadjuvant chemotherapy with camrelizumab

Paclitaxel DRUG

Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles

neoadjuvant chemotherapy with camrelizumab

Neoadjuvant Chemotherapy DRUG

Neoadjuvant Chemotherapy

neoadjuvant chemotherapy with camrelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The age ranged from 18 to 75 years 2. Middle or lower thoracic esophageal carcinoma 3. Gastroscopy showed squamous cell carcinoma 4. The clinical stage was c-txn1-3m0 5. ECOG score was 0-1 6. Can eat semifluid 7. Weight loss less than 20% in 6 months 8. Sign the consent form before treatment 9. 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;
• Liver: serum total bilirubin level ≤ 1.5 times normal upper limit value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times normal upper limit value;
• Kidney: serum creatinine level is lower than 1.5 times of normal upper limit value or creatinine clearance rate ≥ 60ml / min, urea nitrogen ≤ 200mg / L;
• Blood glucose: within the normal range and / or patients with diabetes are under treatment, but the blood glucose is controlled in a stable state;
• Lung function: baseline FEV1 should be at least 2L; if the baseline FEV1 \< 2L, it should be evaluated by surgical experts, and FEV1 \> 800ml after surgery should be predicted;
• Cardiac function: no myocardial infarction within 1 year; no unstable angina pectoris; no symptomatic severe arrhythmia; no cardiac insufficiency.

You may not qualify if:

• 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
• Those who are known to have bleeding diseases or other uncontrollable diseases and are unable to receive surgical treatment
• Findings of physical examination or clinical trials that the researchers believe may interfere with the results or increase the risk of treatment complications for patients
• Function of each organ of the patient:Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence, CT scan at baseline found the presence of idiopathic pulmonary fibrosis; uncontrolled massive pleural effusion or pericardial effusion;
• Unstable systemic concomitant diseases (active infection, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within 6 months, severe mental disorders requiring drug control, liver, kidney or other metabolic diseases, neuropsychiatric diseases such as Alzheimer's disease);
• Poor gastrointestinal function, absorption syndrome and active peptic ulcer;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Xuhui, 200032, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Paclitaxel; Cisplatin; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Combined Modality Therapy; Therapeutics

Central Study Contacts

wang jia lei, doctor

CONTACT

18017312369; haitunqiao@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 20, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

CN (1)