Esophageal CancerNCT04616040
A Real-world Study Evaluating the Usage of Camrelizumab in Chinese Patients With Advanced Esophageal Cancer
An observational study of Esophageal Cancer, run by Peking University at 1 site in China.
Trial summary
The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Camrelizumab
- Type of treatment
- Injection or infusion
- How many people
- 1,030 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: unresectable locally advanced/recurrent or metastatic esophageal cancer
Who may be able to join
- Sign informed consent and voluntarily participate in this study.
- Unresectable locally advanced/recurring or distant metastatic esophageal cancer patients confirmed by histology or cytology (AJCC 8th edition);
- Unresectable locally advanced patients who are unable or unable to receive radical treatment (including radical radio chemotherapy or radical radiotherapy, etc.) may be considered for inclusion;
- Patients who progress or relapse after neoadjuvant or adjuvant therapy may also be considered for inclusion;
- Age ≥ 18 years old;
- The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.
Who cannot join
- Evidence suggests that the patient is pregnant or breastfeeding;
- Other drug blinded clinical trials are currently underway;
- Other situations that are not suitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Non-interventional Registration Study Evaluating the Usage of Camrelizumab in the Treatment of Unresectable Locally Advanced/Recurrent or Metastatic Chinese Patients With Esophageal Cancer
The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world.
- Conditions
- Esophageal Cancer
- Being tested
- Camrelizumab
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.
| Study group | Role | What they receive |
|---|---|---|
| unresectable locally advanced/recurrent or metastatic esophageal cancer | Not described Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of Camrelizumab
especially Occurrence of ≥Grade 3 immune-related AEs
Measured: an expected average of 24 months
Secondary outcomes (4)
Adverse events of Camrelizumab
including other occasional or rare AEs
Measured: an expected average of 24 months
Overall Survival
Duration from the date of initial treatment to the date of death due to any cause
Measured: an expected average of 24 months
Progression-free Survival (PFS)
A duration from the date of initial treatment to radiographic disease progression or death of any cause
Measured: an expected average of 24 months
Objective Response Rate (ORR)
Proportion of objective complete response and partial response patients
Measured: an expected average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,030 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616040
- Sponsor's protocol ID
- LION-EC
- Status last verified
- Nov 2020
- First submitted
- 10 Oct 2020
- Last updated
- 4 Nov 2020
- 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Registration Study Evaluating the Usage of Camrelizumab in the Treatment of Unresectable Locally Advanced/Recurrent or Metastatic Chinese Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT04616040
- Acronym / sponsor ID
- LION-EC
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,030 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Nov 2020 (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.
The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unresectable locally advanced/recurrent or metastatic esophageal cancer | – | Drug: Camrelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- unresectable locally advanced/recurrent or metastatic esophageal cancer
Key inclusion criteria (6 listed)
- Sign informed consent and voluntarily participate in this study.
- Unresectable locally advanced/recurring or distant metastatic esophageal cancer patients confirmed by histology or cytology (AJCC 8th edition);
- Age ≥ 18 years old;
- The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.
Key exclusion criteria (3 listed)
- Evidence suggests that the patient is pregnant or breastfeeding;
- Other drug blinded clinical trials are currently underway;
- Other situations that are not suitable for inclusion in this study.
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 |
|---|---|---|
| CamrelizumabThe recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused. | Drug | unresectable locally advanced/recurrent or metastatic esophageal cancer |
Primary outcome
Adverse events of Camrelizumab
Time frame: an expected average of 24 months
especially Occurrence of ≥Grade 3 immune-related AEs
4 secondary outcomes
Adverse events of Camrelizumab
Time frame: an expected average of 24 months
Overall Survival
Time frame: an expected average of 24 months
Progression-free Survival (PFS)
Time frame: an expected average of 24 months
Objective Response Rate (ORR)
Time frame: an expected average of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Peking University 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Nov 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events of Camrelizumab (time frame: an expected average of 24 months). 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 4 Nov 2020.