Actively Recruiting
Prospective Single-arm Exploratory Study of Camrelizumab Combined With Chemoradiotherapy for Advanced Esophageal Squamous Cell Carcinoma
Led by Fujian Cancer Hospital · Updated on 2023-10-19
75
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of camrelizumab with chemoradiotherapy and chemotherapy in patients with advanced esophageal cancer who have not received any prior systemic antitumor treatment. This prospective single-arm exploratory clinical study aims to assess the safety and effectiveness of these treatments in patients with esophageal squamous cell carcinoma at advanced stages. The study is sponsored by Fujian Cancer Hospital and focuses on advanced first-line treatment for esophageal cancer. Participants will receive camrelizumab 200 mg through intravenous drip every three weeks, along with chemotherapy drugs including paclitaxel at 150 mg/m2 every three weeks and a platinum-based drug such as cisplatin, carboplatin, or nedaplatin. Radiotherapy will be administered at a dose of 5040 cGy over 28 fractions. After 2 to 3 cycles of chemotherapy, patients who show partial response or stable disease will receive local radiotherapy as part of the treatment plan. During the study, participants will be monitored with evaluations of tumor response and safety assessments. Researchers will measure the objective response rate over three years as the primary outcome, along with overall survival and progression-free survival during the same period. Patients will be followed regularly for treatment effects and side effects, and the total duration of participation may extend up to three years to capture long-term outcomes.
CONDITIONS
Brief Title
Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and voluntary participation
- Diagnosed with esophageal squamous cell carcinoma confirmed by pathology or immunohistochemistry
- UICC/AJCC TNM stage IVA or oligometastatic stage IVB
- Expected survival longer than 3 months
- Age between 18 and 75 years
- ECOG performance status of 0 to 2
- No prior systemic anti-tumor therapy for esophageal cancer (including radiotherapy, chemotherapy, targeted therapy, or immunotherapy)
- At least one measurable lesion
- Normal major organ function including specific blood counts and liver and kidney function
- Good compliance and willingness to cooperate with follow-up
You will not qualify if you...
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Poor nutritional status with BMI less than 18.5 kg/m2 unless corrected and evaluated
- Gastrointestinal bleeding exceeding 200 ml per day
- Presence of deep ulcers as determined by investigator
- Allergy to monoclonal antibodies or any components of camrelizumab, paclitaxel, cisplatin, or other platinum drugs
- Prior or current treatment with radiation, chemotherapy, or other antitumor drugs
- Use of immunosuppressive agents or systemic steroids above 10 mg prednisone daily within 2 weeks before study drug
- Live attenuated vaccine received within 4 weeks before first study drug administration
- Major surgery or severe trauma within 4 weeks before starting study drug
- History of active autoimmune disease or requiring immunosuppressive treatment
- History of immunodeficiency, HIV infection, organ or bone marrow transplantation
- Poorly controlled cardiac conditions such as advanced heart failure or recent myocardial infarction
- Severe infection requiring hospitalization within 4 weeks before study drug
- Active or recent pulmonary tuberculosis infection
- Active hepatitis B or C infection
- Other serious medical conditions or factors affecting safety or compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until completion of 2 to 3 cycles of chemotherapy followed by local radiotherapy as appropriate
Participants receive camrelizumab combined with chemoradiotherapy including paclitaxel, platinum drugs, and radiotherapy to treat advanced esophageal squamous cell carcinoma.
Repeated visits every 3 weeks for drug administration and daily visits during radiotherapy sessions
Duration - Up to 3 years after treatment
Participants are monitored for treatment response and long-term outcomes including survival and progression.
Periodic visits for evaluations over 3 years
Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
Research Team
J
Jiancheng Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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