DCF Combined With Camrelizumab in the Treatment of Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell Cancer

NCT04654403

Esophageal Cancer

UNKNOWN NA

Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

NCT05624099

Esophageal Neoplasms Esophageal Diseases Digestive System Neoplasms

RECRUITING PHASE2

Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy（nCT） in the Treatment of Esophageal Squamous Cell Carcinoma

NCT07312578

Esophageal Squamous Cell Carcinoma

ENROLLING_BY_INVITATION PHASE2

A Study of Camrelizumab Combined With Chemotherapy as Neoadjuvant Therapy in Adcanced Esophageal Squamous Cell Carcinoma (ESCC)

NCT04767295

Esophageal Squamous Cell Carcinoma

UNKNOWN PHASE2

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

NCT05182944

Esophageal Cancer

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ESCC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The experimental group

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

Group Type EXPERIMENTAL

Camrelizumab

Intervention Type DRUG

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

DCF

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Camrelizumab

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

Intervention Type 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\<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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No