Esophageal CancerPhase 2NCT04512417
A Clinical Study Of Camrelizumab With Or Without Radiotherapy In The Treatment Of Esophageal Cancer
A Phase 2 study testing Camrelizumab+Radiotherapy and Camrelizumab in people with Esophageal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe and evaluate the efficacy and safety of Camrelizumab combined with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy 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+Radiotherapy and Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2020to 31 Aug 2022
- 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
- 1. Volunteer to participate in clinical research: fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
- 2. Recurrent or metastatic esophageal cancer confirmed by histology or cytology, patients with ≤4 metastatic lesions;
- 3. Progress after first-line chemotherapy;
- 4. There are lesions measurable according to RECIST standards
- 5. Age ≥18 years old and ≤75 years old, regardless of gender
- 6. ECOG physical strength status score is 0～2;
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- 7. Have not received immunotherapy or biological therapy before;
- 8. Hemoglobin ≥90g/L, platelets ≥10×109/L, absolute neutrophil count ≥1.5×109/L;
- 9. Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 mL/min;
- 10. Serum bilirubin≤1.5×UNL, AST (SGOT) and ALT (SGPT)≤2.5×UNL, alkaline phosphatase≤5×UNL;
- 11. No history of interstitial pneumonia or previous interstitial pneumonia;
Who cannot join
- 1. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody treatment, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug;
- 2. Have received radiotherapy in the past, and the tumor in the irradiation field has progressed;
- 3. Metastasis of meninges, pleura or pericardium;
- 4. Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity;
- 5. Patients with severe cardiovascular or pulmonary diseases, interstitial pneumonia or previous history of interstitial pneumonia:
- 6. Patients who cannot understand the test requirements or may not comply with the test requirements;
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- 7. Autoimmune diseases (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next step of screening: type I diabetes, skin that does not require systemic treatment Diseases (such as vitiligo, psoriasis);
- 8. Active hepatitis B or C that requires treatment;
- 9. Suffered from an active infection requiring systemic treatment 14 days before the first administration;
- 10. Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ or malignant disease cured ≥5 years;
- 11. The researcher believes that some obvious diseases should be excluded from this research;
- 12. The dose limit of radiotherapy cannot meet the limit requirement set by this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Province Cancer Hospital
Hanzhou, Zhejiang, 310000
Chen Ming, MD, 0571-88122199, chenming@zjcc.org.cn
About this study
Official title: A Multi-Center, Randomized Controlled, Phase II Clinical Study Of Camrelizumab With Or Without Radiotherapy For The Treatment Of Recurrent Or Metastatic Esophageal Cancer That Has Progressed After Chemotherapy
The purpose of this study is to observe and evaluate the efficacy and safety of Camrelizumab combined with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy
Read the detailed description
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multi-center, randomized controlled, phase II clinical study of camrelizumab with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab with or without radiotherapy for advanced esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- Camrelizumab+Radiotherapy, Camrelizumab
- Keywords
- Esophageal Cancer, Camrelizumab, IO、Radiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab+RadiotherapyDrug
Also called SBRT
The combined treatment group received radiotherapy for recurring or metastatic lesions: at least one or more lesions were irradiated, stereotactic body radiotherapy (SBRT, 8Gy/time, 3-5 times) or conventional radiotherapy (parts not suitable for SBRT, total Dose 30Gy or more); start immunotherapy within 8 weeks after radiotherapy.Until PD or toxicity is intolerable or up to 24 months.
CamrelizumabDrug
Camrelizumab,200mg,Q3W,Until PD or toxicity is intolerable or up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Combined radiotherapy group | Experimental | Not described Receives: Drug: Camrelizumab+Radiotherapy |
| Immunotherapy alone group | Experimental | Not described Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Measured: Up to 24 months
Secondary outcomes (4)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Measured: Up to approximately 6 months.
Overall Survival (OS)
defined as the time from randomization to death from any cause during the course of the study.
Measured: Up to 24 months
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: Up to 24 months
Failure mode
Observe and collect the reasons for the treatment failure of the subjects during the study
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start31 Aug 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2022 (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 Zhejiang Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512417
- Sponsor's protocol ID
- IRB-2020-176
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized Controlled, Phase II Clinical Study Of Camrelizumab With Or Without Radiotherapy For The Treatment Of Recurrent Or Metastatic Esophageal Cancer That Has Progressed After Chemotherapy
- ClinicalTrials.gov ID
- NCT04512417
- Acronym / sponsor ID
- IRB-2020-176
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Camrelizumab, IO、Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 31 Aug 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 13 Aug 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 purpose of this study is to observe and evaluate the efficacy and safety of Camrelizumab combined with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy
Detailed description
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multi-center, randomized controlled, phase II clinical study of camrelizumab with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab with or without radiotherapy for advanced esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined radiotherapy group | Experimental | Drug: Camrelizumab+Radiotherapy |
| Immunotherapy alone group | Experimental | Drug: Camrelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Volunteer to participate in clinical research: fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
- 2. Recurrent or metastatic esophageal cancer confirmed by histology or cytology, patients with ≤4 metastatic lesions;
- 3. Progress after first-line chemotherapy;
- 4. There are lesions measurable according to RECIST standards
- 5. Age ≥18 years old and ≤75 years old, regardless of gender
Key exclusion criteria (12 listed)
- 1. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody treatment, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug;
- 2. Have received radiotherapy in the past, and the tumor in the irradiation field has progressed;
- 3. Metastasis of meninges, pleura or pericardium;
- 4. Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity;
- 5. Patients with severe cardiovascular or pulmonary diseases, interstitial pneumonia or previous history of interstitial pneumonia:
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 |
|---|---|---|
| Camrelizumab+RadiotherapyAlso: SBRTThe combined treatment group received radiotherapy for recurring or metastatic lesions: at least one or more lesions were irradiated, stereotactic body radiotherapy (SBRT, 8Gy/time, 3-5 times) or conventional radiotherapy (parts not suitable for SBRT, total Dose 30Gy or more); start immunotherapy within 8 weeks after radiotherapy.Until PD or toxicity is intolerable or up to 24 months. | Drug | Combined radiotherapy group |
| CamrelizumabCamrelizumab,200mg,Q3W,Until PD or toxicity is intolerable or up to 24 months. | Drug | Immunotherapy alone group |
Primary outcome
Progression-free Survival (PFS) per RECIST 1.1
Time frame: Up to 24 months
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
4 secondary outcomes
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to approximately 6 months.
Overall Survival (OS)
Time frame: Up to 24 months
Number of Subjects with treatment-related adverse events (AEs)
Time frame: Up to 24 months
Failure mode
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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+Radiotherapy and Camrelizumab in people with Esophageal Cancer, run by Zhejiang Cancer 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 12 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 13 Aug 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.
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 Chen Ming, MD (0571-88122199, chenming@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) per RECIST 1.1 (time frame: Up to 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 13 Aug 2020.