Esophageal CancerPhase 2NCT04390945
Camrelizumab Combined With CRT for Treatment of Patients With Local Recurrence of Esophageal Cancer
A Phase 2 study testing Camrelizumab in people with Esophageal Cancer, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
Trial summary
China is a country with a large incidence of esophageal cancer. The prevalence and mortality rate of esophageal cancer in China ranks fifth in the world. However, due to China's huge population base, new patients with esophageal cancer and deaths account for about 55% of the world. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Camrelizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to Aug 2024
- Phase
- Phase 2
- 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, both men and women;
- Histologically confirmed as esophageal cancer;
- Patients with local recurrence of esophageal cancer after radical treatment;
- ECOG: 0 ～ 1;
- Expected survival time ≥ 12 weeks;
- The function of main organs is normal, that is, it meets the following standards:
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- Blood routine examination:
- HB≥90g / L; b.ANC≥1.5 × 109 / L; c.PLT≥80 × 109 / L; (2) Biochemical inspection:
- ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; 7. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days before the study enrollment , and must be a non-lactating patient; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 8. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Who cannot join
- Does not meet the above selection criteria;
- Patients with distant visceral metastasis;
- Patients with recurrence time <10 months receiving radical radiotherapy
- Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;
- The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism; The patient has vitiligo; Asthma has been completely relieved in childhood and can be included without any intervention after adulthood; Patients with asthma requiring medical intervention with bronchodilators cannot be included);
- The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose> 10mg / day prednisone or other therapeutic hormones), and is still using it within 2 weeks before enrollment
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- Contraindications to radiotherapy;
- Severe infections that are active or uncontrolled;
- Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA≥104 copies / ml or 2000IU / ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the analytical method.
- Patients whose imaging has shown that the tumor has invaded the important blood vessels or the investigator judges that the tumor is likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study;
- Pregnant or lactating women;
- Patients with other malignant tumors within 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ);
- Patients with a history of psychotropic substance abuse who are unable to quit or have mental disorders;
- Patients who have participated in clinical trials of other drugs within four weeks;
- According to the judgment of the investigator, there are patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
- The investigator considers it unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 470000
Ruinuo Jia, doctor
About this study
Official title: Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer
China is a country with a large incidence of esophageal cancer. The prevalence and mortality rate of esophageal cancer in China ranks fifth in the world. However, due to China's huge population base, new patients with esophageal cancer and deaths account for about 55% of the world. This study aimed to explore the efficacy and safety of Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer.
Read the detailed description
This is an open clinical study to evaluate the efficacy and safety of Camrelizumab combined with Concurrent Radiotherapy and Chemotherapy in the treatment of locally recurrent esophageal cancer.
Objective to study patients with local recurrence of esophageal cancer after radical treatment.
The study will take progression free survival (PFS) as the main efficacy index, and plan to enroll about 62 patients with local recurrence of esophageal cancer after radical treatment. After fully informed and signed the informed consent, the subjects will enter the experimental stage after screening.
- 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
Also called Capecitabine, concurrent radiotherapy
Camrelizumab combined with concurrent radiotherapy and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy | Experimental | Camrelizumab (200mg Q2W, continuous medication until disease progression, intolerable toxicity, or withdrawal due to other reasons) Simultaneous radiotherapy (50-50.4Gy / 1.8-2Gy / 25-28F) Chemotherapy (Capecitabine, 625mg/m2, bid, oral, d1-5, qw, total 5 weeks). Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival，PFS
Time from randomization to patient's tumor progression or death
Measured: 9 months
Secondary outcomes (2)
Overall survival，OS
The time from the beginning of randomization to death due to any cause.
Measured: 1 year
Objective Response Rate, ORR
The proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Dec 2021
- Primary completionOct 2023 (estimated)
- Study completionAug 2024 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390945
- Sponsor's protocol ID
- FirstHenanUST-EC
- Status last verified
- Jan 2022
- First submitted
- 13 May 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT04390945
- Acronym / sponsor ID
- FirstHenanUST-EC
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 18 May 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.
China is a country with a large incidence of esophageal cancer. The prevalence and mortality rate of esophageal cancer in China ranks fifth in the world. However, due to China's huge population base, new patients with esophageal cancer and deaths account for about 55% of the world. This study aimed to explore the efficacy and safety of Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Treatment of Patients With Local Recurrence of Esophageal Cancer.
Detailed description
This is an open clinical study to evaluate the efficacy and safety of Camrelizumab combined with Concurrent Radiotherapy and Chemotherapy in the treatment of locally recurrent esophageal cancer.
Objective to study patients with local recurrence of esophageal cancer after radical treatment.
The study will take progression free survival (PFS) as the main efficacy index, and plan to enroll about 62 patients with local recurrence of esophageal cancer after radical treatment. After fully informed and signed the informed consent, the subjects will enter the experimental stage after screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy | Experimental | Drug: CamrelizumabCamrelizumab (200mg Q2W, continuous medication until disease progression, intolerable toxicity, or withdrawal due to other reasons) Simultaneous radiotherapy (50-50.4Gy / 1.8-2Gy / 25-28F) Chemotherapy (Capecitabine, 625mg/m2, bid, oral, d1-5, qw, total 5 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years old, both men and women;
- Histologically confirmed as esophageal cancer;
- Patients with local recurrence of esophageal cancer after radical treatment;
- ECOG: 0 ～ 1;
- Expected survival time ≥ 12 weeks;
Key exclusion criteria (16 listed)
- Does not meet the above selection criteria;
- Patients with distant visceral metastasis;
- Patients with recurrence time <10 months receiving radical radiotherapy
- Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;
- The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism; The patient has vitiligo; Asthma has been completely relieved in childhood and can be included without any intervention after adulthood; Patients with asthma requiring medical intervention with bronchodilators cannot be included);
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 |
|---|---|---|
| CamrelizumabAlso: Capecitabine, concurrent radiotherapyCamrelizumab combined with concurrent radiotherapy and chemotherapy | Drug | Camrelizumab Combined With Concurrent Radiotherapy and Chemotherapy |
Primary outcome
Progression-free survival，PFS
Time frame: 9 months
Time from randomization to patient's tumor progression or death
2 secondary outcomes
Overall survival，OS
Time frame: 1 year
Objective Response Rate, ORR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab in people with Esophageal Cancer, run by The First Affiliated Hospital of Henan University of Science and Technology 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 9 inclusion and 16 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 3 Feb 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ruinuo Jia (18537950766, jiaruinuo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival，PFS (time frame: 9 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 3 Feb 2022.