A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCC

Recruiting now · Phase 2

Conditions studied: Esophageal Cancer

In brief

The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.

Key facts

Study ID

NCT05182944

Run by

The First Affiliated Hospital of Zhengzhou University

People needed

130

Starts

2022-01-15

Expected to finish

2027-01-15

Last updated by the study team

2022-05-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Cervical esophageal squamous cell carcinoma;
• Combined with cervical, supraclavicular, abdominal, retroperitoneal and pelvic lymph node metastasis (except pericardial lymph node metastasis and left gastric lymph node metastasis);
• Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
• Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
• Previously active, potentially relapsed or undiagnosed autoimmune diseases, skin diseases (vitiligo, psoriasis, alopecia) without systemic treatment, well controlled type I diabetes, hypothyroidism (only thyroid hormone replacement therapy), and other diseases that were not expected to relapse under external stimulation were included.
• History of allogeneic stem cell transplantation or organ transplantation;
• Complicated with interstitial pneumonia or interstitial lung disease, non infectious pneumonia;
• History of gastrointestinal perforation and/or fistula, abdominal abscess, visceral fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive within 6 months before the first study drug administration bowel resection (including partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea;
• Major operations (except puncture and biopsy) or major trauma were performed ≤ 28 days before the administration of the first study drug;
• Have vaccinated or plan to vaccinate live vaccine within 28 days before the first study drug administration;
• Use corticosteroids (>10 mg/day prednisone or equivalent dose) or other immunosuppressive agents within 14 days before the first study drug administration. Inhalation, ophthalmic, intra-articular, intranasal or topical corticosteroids can be used prophylactically for short-term (≤7 days) use of corticosteroids (for example, to prevent allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity caused by contact with allergens)
• Infectious diseases that affect activities of daily living or require systemic treatment (such as the use of hormones, antibiotics, antifungal drugs, antiviral drugs, and oxygen inhalation) within 14 days before the first study drug administration, including but not limited to the need Hospitalized infections, bacteremia, severe pneumonia, etc.;
• Combined with the following diseases that have not been well controlled, such as: a) New York Heart Association (NYHA) ≥ Grade 2 heart failure, b) Severe/Unstable Angina, c) Myocardial infarction ≤ 6 months before study administration, d) Severe arrhythmia requiring medication or intervention, e) Uncontrollable hypertension, f) Occurrence/combined arterial and/or venous thromboembolism ≤2 months before the first study administration, g) ≤6 before the first study administration A cerebrovascular accident occurred within a month, h) diabetes that has not been effectively controlled, i) thyroid disease that has not been effectively controlled, j) urine protein ≥ 2+ and 24-hour urine protein quantification ≥ 1.0g;
• Tuberculosis (TB) who has received anti-tuberculosis treatment within 1 year before receiving/receiving/first study administration;
• Human immunodeficiency virus infection (HIV1/2 antibody positive);
• Acute or chronic active hepatitis B and / or hepatitis C: positive for hepatitis B virus surface antigen (HBsAg) / positive for hepatitis B virus core antibody (HBcAb) and positive for hepatitis B virus DNA (HBV DNA >2000 IU/ml or 103 copies /ml), if HBsAg/HB cAb positive, HBV DNA less than 2000 IU/ml or 103 copies of /ml can be entered, but entecavir or other anti HBV drugs should be taken simultaneously; hepatitis C virus (positive) antibody is positive and HBV copies;
• Pregnant or lactating women;
• Complicated with other malignant tumors ≤5 years before the first study drug administration, various cancers in situ, skin basal cell carcinoma or squamous cell carcinoma that have been cured in the past, local prostate cancer after radical resection, and catheters after radical resection except for carcinoma in situ;
• Combined with other severe, acute, chronic or mental illness that may increase the risk of study medication or may interfere with the interpretation of the study results, the presence of alcoholism, drug abuse, or drug abuse, and other conditions that are not conducive to study drug administration, drug toxicity or adverse events (AE) Circumstances that lead to a decrease in the compliance of research behavior;
• Other circumstances that the researcher considers inappropriate to participate in the study.

Where it is running

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)

Full record on ClinicalTrials.gov

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