DCF Combined With Camrelizumab in the Treatment of Esophageal Cancer

NCT05050760 | Unknown

• 1 other identifier: KY20212101-C-1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ESCC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pathologic Complete Response (PCR)

  1 month after resection

• Major pathologic response (MPR)

  1 month after resection

• Disease Free Survival (DFS)

  3 and 5 years

Study Arms (1)

The experimental group

EXPERIMENTAL

Drug：DCF+Camrelizumab Camrelizumab:200mg/time,IV,Q3W

Drug: Camrelizumab; Drug: DCF

Interventions

Camrelizumab DRUG

Camrelizumab 200mg IV D1，Q3W,and preoperative therapy with three cycles.

The experimental group

DCF DRUG

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\<BSA\<1.5\^2,50 mg/time,BID ,after breakfast and dinner, continuous administration for 14 days, rest for 7 days, as a treatment cycle;Repeat every 3 weeks

The experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Demonstrate adequate organ function.
• 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.
• The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.

You may not qualify if:

• 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).
• Significant active infection is known, or the investigator determines the presence of significant blood, renal, metabolic, gastrointestinal, or endocrine dysfunction.
• Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• 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.
• 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).
• Those who had received live vaccine within 3 months prior to treatment.
• In the midst of acute or chronic tuberculosis infection.
• Patients were enrolled in clinical trials of other antitumor drugs within 4 weeks.
• IV fluids cannot be administered.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Interventions

camrelizumab

Study Officials

• Jianjun Yang

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun Yang, Dr.

CONTACT

0086-13572533693; Jianjunyang66@hotmail.com

Guanghui Xu, Dr.

CONTACT

0086-17791826711; xuguanghui8@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients fulfilling Eligibility Criteria will be included in our study.After three cycles of resectable esophageal cancer treated with DCF combined with camrelizumab neoadjuvant therapy, the researchers determined whether the patient should undergo surgical treatment according to clinical diagnosis and patient willingness.If the patient underwent surgery, surgery was performed 6-8 weeks after discontinuation;If the patient did not receive surgical treatment, the patient was continued to receive 3 cycles of adjuvant therapy with camrelizumab combined with DCF regimen

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: September 21, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 31, 2023

Record last verified: 2022-08

Locations

CN (1)