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Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell

18. august 2020 opdateret af: Jialei Wang, Fudan University

A Prospective, Single Arm, Single Center, Phase II Clinical Trial of Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell

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

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Xuhui
      • Shanghai, Xuhui, Kina, 200032
        • Rekruttering
        • Cancer hospital Fudan University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

1. 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:

  1. 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;
  2. 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;
  3. 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;
  4. Blood glucose: within the normal range and / or patients with diabetes are under treatment, but the blood glucose is controlled in a stable state;
  5. 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;
  6. Cardiac function: no myocardial infarction within 1 year; no unstable angina pectoris; no symptomatic severe arrhythmia; no cardiac insufficiency.

Exclusion Criteria:

  1. The pathological findings were complex squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc
  2. He had a history of subtotal gastrectomy
  3. Patients with secondary primary cancer at the same time
  4. The patients with distant metastasis indicated by imaging before treatment
  5. Except for skin basal cell carcinoma, skin squamous cell carcinoma and / or cervical carcinoma in situ after effective treatment
  6. Patients who have received chemoradiotherapy in the past
  7. There were signs of esophageal perforation
  8. Pregnant women of childbearing age
  9. The patient has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, etc.)
  10. 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
  11. Those who are known to have bleeding diseases or other uncontrollable diseases and are unable to receive surgical treatment
  12. 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
  13. 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;
  14. 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);
  15. Poor gastrointestinal function, absorption syndrome and active peptic ulcer;
  16. Have received any of the following treatments:

1) Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past; 2) Received any research drug within 4 weeks before the first use of the study drug; 3) At the same time, they were enrolled in another clinical study, unless it was an observational (non intervention) clinical study or an intervention clinical study follow-up; 4) Have received any anti-tumor treatment related to esophageal cancer, including but not limited to radiotherapy, chemotherapy, surgery, ESD, EMR, immunotherapy, targeted therapy, and traditional Chinese medicine treatment; 5) Subjects who needed systemic treatment with corticosteroids (10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks before the first use of the study drug were excluded from the use of corticosteroids for local esophageal inflammation and prevention of allergy, nausea and vomiting. Other special circumstances, need to communicate with the sponsor. In the absence of active autoimmune disease, inhaled or topical corticosteroids and corticosteroids with dose > 10 mg / day prednisone were allowed to be used instead; 6) Those who have received anti-tumor vaccine or received live vaccine within 4 weeks before the first administration of the study drug; 7) Major surgery or severe trauma occurred within 4 weeks before the first use of the study drug; 17. History of congenital or acquired immunodeficiency disease or organ transplantation; 18. He had a history of allergy to monoclonal antibodies, paclitaxel, cisplatin and other platinum drugs;

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Carilizumab 200 mg, every 3 weeks, 2 cycles.Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles
Andre navne:
  • Cisplatin
  • Paclitaxel
Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
Neoadjuvant Chemotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pathological complete response rate (pCR)
Tidsramme: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)
Pathological complete response rate
from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2020

Primær færdiggørelse (Forventet)

31. december 2021

Studieafslutning (Forventet)

31. december 2021

Datoer for studieregistrering

Først indsendt

12. august 2020

Først indsendt, der opfyldte QC-kriterier

18. august 2020

Først opslået (Faktiske)

20. august 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med PFS

Kliniske forsøg med camrelizumab

Abonner