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New treatment option for Esophageal Neoplasms
Official title Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.
ClinicalTrials.gov ID: NCT05624099
What this study is testing
What is camrelizumab?
camrelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Survival is expected to exceed 3 months
- Age 18-75;
- ECOG PS 0-2
You likely can't join if
- 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...
- 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:
See the full eligibility 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 ≥...
- 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
- people have good compliance and cooperate with follow-up
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.