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Compares treatment options for Resectable Esophageal Squamous Cell Carcinoma
Official title Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.
ClinicalTrials.gov ID: NCT05043688
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, being studied as a potential treatment for resectable esophageal squamous cell carcinoma.
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
- The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.
- Phase 3: a large, late-stage study
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
- The result of pathological biopsy showed esophageal squamous cell carcinoma;
- Have not received systemic or local treatment for esophageal cancer in the past;
- Age 18-75 years (including 18 and 75 years old), both male and female;
- ECOG score 0-1;
- Thoracic esophageal cancer assessed by CT/MRI/PET-CT etc. as resectable and the clinical stage is T1b-3N1-3M0 or T3N0M0, according to the 8th edition...
You likely can't join if
- There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery;
- Patients with supraclavicular lymph node metastasis;
- Poor nutritional status, BMI \<18.5 Kg/m2; if the symptomatic nutritional support is corrected before randomization, the main investigator can...
- Those who are known to have a history of allergies to the drug components of this program;
- Have received or are receiving any of the following treatments in the past:
- Any radiotherapy, chemotherapy or other anti-tumor drugs for tumors;
See the full eligibility criteria
- The result of pathological biopsy showed esophageal squamous cell carcinoma;
- Have not received systemic or local treatment for esophageal cancer in the past;
- Age 18-75 years (including 18 and 75 years old), both male and female;
- ECOG score 0-1;
- Thoracic esophageal cancer assessed by CT/MRI/PET-CT etc. as resectable and the clinical stage is T1b-3N1-3M0 or T3N0M0, according to the 8th edition of AJCC staging;
- Those who are expected to achieve R0 resection;
- Voluntarily sign an informed consent form before treatment;
- Plan to receive surgical treatment after neoadjuvant treatment is completed;
- No surgical contraindications;
- Normal function of major organs
- Female people with fertility must undergo a serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraception during the trial and at least...
- The people have good compliance and can follow up the how well it works and adverse events/reactions according to the requirements of the plan;
- There are unresectable factors, including unresectable tumors, unresectable contraindications for surgery, or rejection of surgery;
- Patients with supraclavicular lymph node metastasis;
- Poor nutritional status, BMI \<18.5 Kg/m2; if the symptomatic nutritional support is corrected before randomization, the main investigator can continue to consider it after evaluation;
- Those who are known to have a history of allergies to the drug components of this program;
- Have received or are receiving any of the following treatments in the past:
- Any radiotherapy, chemotherapy or other anti-tumor drugs for tumors;
- Immunosuppressive drugs or systemic hormone drugs are being used within 2 weeks before the first use of the study drug to achieve immunosuppressive purposes (dose\>10mg/day prednisone or equivalent dose); if there is no...
- Received a live attenuated vaccine within 4 weeks before using the study drug for the first time;
- Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time;
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
- There are clinical symptoms or diseases of the heart that are not well controlled;
- Severe infections (CTCAE v5.0\> level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest...
- Participated in other drug clinical studies within 4 weeks before randomization;
- People who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy, or have other...
- Patients with any active autoimmune diseases or history of autoimmune diseases with the possibility of recurrence; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair...
- There is active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analytical method);
- Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, unless malignant tumors with low risk of metastasis or death (5-year survival rate\> 90%), such as fully treated skin...
- Women who are pregnant or breastfeeding;
- According to the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as suffering from other serious diseases (including mental illness) requiring combined...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Anyang, China
- Guangzhou, China
- Hefei, China
- Shanghai, 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 Shanghai, Shanghai Municipality, China; Anyang, China; Guangzhou, China; Hefei, China; Shanghai, 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.