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Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell

18. august 2020 oppdatert av: 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

Studieoversikt

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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 navn:
  • Cisplatin
  • Paklitaksel
Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
Neoadjuvant Chemotherapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2020

Primær fullføring (Forventet)

31. desember 2021

Studiet fullført (Forventet)

31. desember 2021

Datoer for studieregistrering

Først innsendt

12. august 2020

Først innsendt som oppfylte QC-kriteriene

18. august 2020

Først lagt ut (Faktiske)

20. august 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2020

Sist bekreftet

1. august 2020

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på PFS

Kliniske studier på camrelizumab

3
Abonnere