UnknownNot Applicable

DCF Combined With Camrelizumab in the Treatment of Esophageal Cancer

China55 participantsStarted 2021-09-01

Plain-language summary

To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18-75 years old patients with esophageal cancer, male and female.
✓. A patient with esophageal squamous cell carcinoma diagnosed by pathology.
✓. Initial treatment, no previous surgery.
✓. Subjects were patients with resectable locally advanced ESCC(AJCC V8 TNM classification),tumor node metastasis classification(TNM)
✓. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale.
✓. Expected survival ≥ 3 months.
✓. All patients should have measurable or evaluable target lesions.
✓. Able to eat more than a liquid diet; No preesophageal perforation signs; There was no distant metastasis and the operation was tolerated.

✕. Patients who did not meet the inclusion criteria for pathological type and primary site.
✕. Known to be allergic to macromolecular protein preparations, or components of carilizumab, or to loplatin, docetaxa, sergiol, contrast agents and their preparations.
✕. Risk of esophageal perforation or presence of esophageal ulcers.
✕. There is evidence of distant organ metastasis.
✕. Surgical treatment (except biopsy), radiotherapy, chemotherapy, and molecular targeted therapy have been performed.
✕. had other malignant tumors ever.
✕. History of severe lung or heart disease.
✕. Active infection or fever of unknown cause \> 38.5℃ in the 2 weeks prior to randomization (fever due to tumor can be included in the study as determined by the investigator).

Safety and Feasibility（Incidence of Treatment-Emergent Adverse Events）

Timeframe: 12months

NCT IDNCT05050760

SponsorXijing Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Jianjun Yang, Dr.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18-75 years old patients with esophageal cancer, male and female.
✓. A patient with esophageal squamous cell carcinoma diagnosed by pathology.
✓. Initial treatment, no previous surgery.
✓. Subjects were patients with resectable locally advanced ESCC(AJCC V8 TNM classification),tumor node metastasis classification(TNM)
✓. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale.
✓. Expected survival ≥ 3 months.
✓. All patients should have measurable or evaluable target lesions.
✓. Able to eat more than a liquid diet; No preesophageal perforation signs; There was no distant metastasis and the operation was tolerated.

✕. Patients who did not meet the inclusion criteria for pathological type and primary site.
✕. Known to be allergic to macromolecular protein preparations, or components of carilizumab, or to loplatin, docetaxa, sergiol, contrast agents and their preparations.
✕. Risk of esophageal perforation or presence of esophageal ulcers.
✕. There is evidence of distant organ metastasis.
✕. Surgical treatment (except biopsy), radiotherapy, chemotherapy, and molecular targeted therapy have been performed.
✕. had other malignant tumors ever.
✕. History of severe lung or heart disease.
✕. Active infection or fever of unknown cause \> 38.5℃ in the 2 weeks prior to randomization (fever due to tumor can be included in the study as determined by the investigator).