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Recruiting

NCT Number: NCT05624099

Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fujian Cancer Hospital

Fuzhou, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sign written informed consent and voluntarily participate in this study;
  • Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB;
  • Survival is expected to exceed 3 months
  • Age 18-75;
  • ECOG PS 0-2
  • Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy;
  • Have at least one measurable lesion
  • Normal function of major organs, including:
  • Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs)

White blood cell count ≥ 3.0×10^9/L

Neutrophil count ≥ 1.0×10^9/L

Platelet count ≥ 80×109/L

Hemoglobin ≥ 80 g/L

  • Blood biochemical examination:

Total bilirubin ≤ 1.5×ULN

ALT ≤2.5×ULN, AST ≤2.5×ULN,

Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL/min

  • Subjects have good compliance and cooperate with follow-up

Exclusion criteria

  • The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage;
  • Poor nutritional status, BMI < 18.5 Kg/m^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator;
  • Gastrointestinal bleeding (bleeding volume > 200ml/ day);
  • Patients with deep ulcers as determined by the investigator;
  • Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs;
  • Has received or is receiving any of the following medical treatment:
  • any radiation, chemotherapy or other antitumor drugs for the tumor;
  • Being treated with immunosuppressive agents or systemic hormones for immunosuppression purposes (dose >10mg/ day prednisone or equivalent) within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of >10mg/ day or its equivalent are permitted;
  • Received live attenuated vaccine within 4 weeks before the first administration of the study drug;
  • Major surgery or severe trauma within 4 weeks before the first use of the study drug;
  • A history of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which may be considered for inclusion after hormone replacement therapy); Patients with complete remission of psoriasis or childhood asthma/allergies who did not require any intervention as adults were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included;
  • A history of immunodeficiency, including being HIV positive, or suffering from another acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
  • The presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to:

Such as (1) NYHAII grade or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention;

  • Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging examination indicated active pulmonary inflammation, signs and symptoms of infection within 14 days before the first use of study drugs, or the need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use;
  • Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment;
  • The presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (HCV antibody positive and HCV RNA above the assay limit);
  • In the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as the presence of other serious medical conditions (including mental illness) requiring concomitant treatment, alcoholism, substance abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.

Treatment and study plan

Camrelizumab

Drug

200mg intravenous drip d1q3w

Paclitaxel drugs

Drug

150mg/m2 d1 q3w

Platinum drug

Drug

Cisplatin, carboplatin, nedaplatin and other platinum drugs

Radiation

Radiation

Dose: 5040cGy/28f

Primary outcomes

  1. Objective Response Rate(ORR)

    Time frame: 3 years

    ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

Secondary outcomes

  1. Overall survival(OS)

    Time frame: 3 years

    Defined as the time from the enrollment to death from any cause

  2. Progression free survival(PFS)

    Time frame: 3 years

    It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiancheng Li, Doctor

CONTACT

[email protected]

13906900190

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

Prospective Single-arm, Exploratory, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemoradiotherapy in the Treatment of Advanced First-line Esophageal Phosphorous Carcinoma

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Nov 21, 2022
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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