Advanced Esophageal CancerPhase 2NCT05174156
Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer
A Phase 2 study testing Combination therapy in people with Advanced Esophageal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Cancer
- What is being tested?
- Combination therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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
- Unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
- Not received any previous systematic antitumor therapy.
- Eastern Cooperative Oncology Group (ECOG) fitness status score was 0 or 1 within 3 days before the first administration of the intervention.
- 8-10 tumor tissue samples can be provided.
- Demonstrate good organ and bone marrow function.
- Consent to participate in the contraceptive methods related to clinical research.
Who cannot join
- Have a history of allergy to monoclonal antibodies, any component of SHR-1210, albumin-paclitaxel, carboplatin, and other platinum drugs;
- Weight loss > 20% in the past 3 months.
- Major surgery within 28 days prior to enrollment.
- Have received systemic chemotherapy or radiation therapy for esophageal cancer.
- Had a myocardial infarction within the past 6 months.
- Have any medical history or current evidence, treatment, or laboratory abnormalities that prevent the subject from participating fully in the study with the investigator's opinion.
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- Prior treatment with immunotherapy drugs.
- Received live vaccine within 30 days prior to initial administration of the investigational drug.
- Have been diagnosed with immunodeficiency or are receiving immunosuppressive treatment.
- Another malignancy is known to exist.
- Have active infections that require systemic treatment.
- Pregnant or lactating, or planning to become pregnant or become a father during the study period (180 days for lactating subjects receiving carboplatin) from the beginning of the screening visit until 120 days after the last dose of the study intervention.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Hongying Liao, Professor, 13928845885, hylmed1996@126.com
Hongying Liao, Professor
About this study
This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.
- Conditions
- Advanced Esophageal Cancer
- Being tested
- Combination therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapyDrug
SHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin
| Study group | Role | What they receive |
|---|---|---|
| biomarker study and treatment study | Experimental | All enrolled patients undergo biomarker study and treatment study.
* Biomarker study: the baseline tumor tissue will be collected and analyzed via NGS and mIHC
* Treatment study: SHR-1210 plus albumin-bound paclitaxel and platinum-based chemotherapy Receives: Drug: Combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Measured: up to approximately 1 year
Secondary outcomes (4)
Progression-Free Survival (PFS)
It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Measured: up to approximately 1 year
Overall Survival (OS)
Defined as the time from the enrollment to death from any cause
Measured: up to approximately 1 year
Disease Control Rate (DCR)
The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1.
Measured: up to approximately 1 year
Adverse events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
Measured: up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc., Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174156
- Sponsor's protocol ID
- ESCC-IO-BIO-1
- Status last verified
- Jul 2022
- First submitted
- 15 Dec 2021
- Last updated
- 14 Jul 2022
- Results posted
- No
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05174156
- Acronym / sponsor ID
- ESCC-IO-BIO-1
- Conditions
- Advanced Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc., Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Dec 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.
This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biomarker study and treatment study | Experimental | Drug: Combination therapyAll enrolled patients undergo biomarker study and treatment study. * Biomarker study: the baseline tumor tissue will be collected and analyzed via NGS and mIHC * Treatment study: SHR-1210 plus albumin-bound paclitaxel and platinum-based chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unresectable locally advanced/ recurrent or distant metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
- Not received any previous systematic antitumor therapy.
- Eastern Cooperative Oncology Group (ECOG) fitness status score was 0 or 1 within 3 days before the first administration of the intervention.
- 8-10 tumor tissue samples can be provided.
- Demonstrate good organ and bone marrow function.
Key exclusion criteria (12 listed)
- Have a history of allergy to monoclonal antibodies, any component of SHR-1210, albumin-paclitaxel, carboplatin, and other platinum drugs;
- Weight loss > 20% in the past 3 months.
- Major surgery within 28 days prior to enrollment.
- Have received systemic chemotherapy or radiation therapy for esophageal cancer.
- Had a myocardial infarction within the past 6 months.
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 |
|---|---|---|
| Combination therapySHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin | Drug | biomarker study and treatment study |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to approximately 1 year
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: up to approximately 1 year
Overall Survival (OS)
Time frame: up to approximately 1 year
Disease Control Rate (DCR)
Time frame: up to approximately 1 year
Adverse events (AEs)
Time frame: up to approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- 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 Combination therapy in people with Advanced Esophageal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen 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 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 14 Jul 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 Hongying Liao, Professor (+86 13928845885, hylmed1996@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to approximately 1 year). 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 14 Jul 2022.