ESCCNCT05050760
DCF Combined With Camrelizumab in the Treatment of Esophageal Cancer
A study testing Camrelizumab and DCF in people with ESCC, run by Xijing Hospital at 1 site in China.
Trial summary
To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESCC
- What is being tested?
- Camrelizumab and DCF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- She has a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation.
- Have a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710000
Jianjun Yang, Dr., 0086-13572533693, Jianjunyang66@hotmail.com
Guanghui Xu, Dr., 0086-17791826711, xuguanghui8@126.com
About this study
Official title: 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
Read the 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
- Conditions
- ESCC
- Being tested
- Camrelizumab, DCF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab 200mg IV D1，Q3W,and preoperative therapy with three cycles.
DCFDrug
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
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Drug：DCF+Camrelizumab Camrelizumab:200mg/time,IV,Q3W Receives: Drug: Camrelizumab; Drug: DCF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12months
Secondary outcomes (3)
Pathologic Complete Response (PCR)
PCR is defined as pT0N0M0
Measured: 1 month after resection
Major pathologic response (MPR)
MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens.
Measured: 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.
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Sep 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianjun Yang, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050760
- Sponsor's protocol ID
- KY20212101-C-1
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05050760
- Acronym / sponsor ID
- KY20212101-C-1
- Conditions
- ESCC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Drug: Camrelizumab, Drug: DCFDrug：DCF+Camrelizumab Camrelizumab:200mg/time,IV,Q3W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamrelizumabCamrelizumab 200mg IV D1，Q3W,and preoperative therapy with three cycles. | Drug | The experimental group |
| DCFDCF: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 | Drug | The experimental group |
Primary outcome
Safety and Feasibility（Incidence of Treatment-Emergent Adverse Events）
Time frame: 12months
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).
3 secondary outcomes
Pathologic Complete Response (PCR)
Time frame: 1 month after resection
Major pathologic response (MPR)
Time frame: 1 month after resection
Disease Free Survival (DFS)
Time frame: 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianjun Yang principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camrelizumab and DCF in people with ESCC, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianjun Yang, Dr. (0086-13572533693, Jianjunyang66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Feasibility（Incidence of Treatment-Emergent Adverse Events） (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.