DCF Combined With Camrelizumab in the Treatment of Esophageal Cancer

An Exploratory Study of the Efficacy and Safety of DCF Regimen Combined With Camrelizumab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma(ESCC)

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

Study Overview

• Status: Recruiting
• Conditions: ESCC
• Intervention / Treatment: Drug: Camrelizumab; Drug: DCF

Detailed Description

Primary outcome:

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

Secondary outcome:

pathologic complete response (pCR)、Major Pathologic Response（MPR）、R0 resection rate、Objective response rate（ORR）、Disease free survival（DFS）、Relief rate and safety of dysphagia

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianjun Yang, Dr.; Phone Number: 0086-13572533693; Email: Jianjunyang66@hotmail.com
• Study Contact Backup: Name: Guanghui Xu, Dr.; Phone Number: 0086-17791826711; Email: xuguanghui8@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • Xijing Hospital
      • Contact: Jianjun Yang, Dr.; Phone Number: 0086-13572533693; Email: Jianjunyang66@hotmail.com
      • Contact: Guanghui Xu, Dr.; Phone Number: 0086-17791826711; Email: xuguanghui8@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-75 years old patients with esophageal cancer, male and female.
2. A patient with esophageal squamous cell carcinoma diagnosed by pathology.
3. Initial treatment, no previous surgery.
4. Subjects were patients with resectable locally advanced ESCC(AJCC V8 TNM classification),tumor node metastasis classification(TNM)
5. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale.
6. Expected survival ≥ 3 months.
7. All patients should have measurable or evaluable target lesions.
8. Able to eat more than a liquid diet; No preesophageal perforation signs; There was no distant metastasis and the operation was tolerated.
9. Demonstrate adequate organ function.
10. Male subjects whose partners are women of childbearing age should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study administration.
11. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.

Exclusion Criteria:

1. Patients who did not meet the inclusion criteria for pathological type and primary site.
2. Known to be allergic to macromolecular protein preparations, or components of carilizumab, or to loplatin, docetaxa, sergiol, contrast agents and their preparations.
3. Risk of esophageal perforation or presence of esophageal ulcers.
4. There is evidence of distant organ metastasis.
5. Surgical treatment (except biopsy), radiotherapy, chemotherapy, and molecular targeted therapy have been performed.
6. had other malignant tumors ever.
7. History of severe lung or heart disease.
8. 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).
9. Significant active infection is known, or the investigator determines the presence of significant blood, renal, metabolic, gastrointestinal, or endocrine dysfunction.
10. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
11. Subjects requiring systematic treatment with corticosteroids (>10mg/ day of prednisone efficacy dose) or other immunosuppressive agents within 14 days prior to the first study drug. In the absence of active autoimmune disease, inhaled or topical steroid use and adrenal corticosteroid replacement at a dose >10mg/ day of prednisone efficacy dose were permitted.
12. Participants had active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), and hepatitis C (HCV antibody positive and HCV-RNA higher than the lower limit of the assay).
13. Those who had received live vaccine within 3 months prior to treatment.
14. In the midst of acute or chronic tuberculosis infection.
15. Patients were enrolled in clinical trials of other antitumor drugs within 4 weeks.
16. IV fluids cannot be administered.
17. She has a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation.
18. Have a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group; Drug：DCF+Camrelizumab Camrelizumab:200mg/time,IV,Q3W	Drug: Camrelizumab; Camrelizumab 200mg IV D1，Q3W,and preoperative therapy with three cycles.; Drug: DCF; DCF:Oxaliplatin (85mg/ m^2, IV D1,Q3W.Docetaxel: 60 mg/m^2 intravenous infusion for 60 minutes, D1,Q3W.Tegafur:BSA<1.25^2,40 mg/time,1.25^2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Feasibility（Incidence of Treatment-Emergent Adverse Events）	All participants with treatment-related adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Event,Version 5.0(CTC AE5.0).	12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic Complete Response (PCR)	PCR is defined as pT0N0M0	1 month after resection
Major pathologic response (MPR)	MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens.	1 month after resection
Disease Free Survival (DFS)	Percentage of Participants With DFS, as Assessed by RECIST 1.1. DFS is defined as the time from randomization to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.	3 and 5 years

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Jianjun Yang, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: KY20212101-C-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No