Advanced Esophageal CancerPhase 2NCT05425472
A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
A Phase 2 study testing HR070803 in people with Advanced Esophageal Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of 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?
- HR070803
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2022to 30 Mar 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
- ECOG performance status 0 or 1
- Histologically confirmed advanced esophageal carcinoma
- At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
- Able and willing to provide a written informed consent
Who cannot join
- The tumor obviously invades adjacent organs of esophageal lesions
- BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening
- Subjects with unresolved adverse effects of prior therapy at the time of enrolment
- Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Kuaile Zhao
About this study
Official title: An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.
- Conditions
- Advanced Esophageal Cancer
- Being tested
- HR070803
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR070803Drug
HR070803
| Study group | Role | What they receive |
|---|---|---|
| HR070803 | Experimental | HR070803 monotherapy will be administered by intravenous infusion Receives: Drug: HR070803 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The study is designed to evaluate the objective response rate of HR070803 in patients with advanced esophageal cancer. ORR is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST version 1.1.
Measured: for 4 months following the date the last patient was randomized
Secondary outcomes (6)
Progression Free Survival
The study is designed to evaluate the progression free survival of HR070803 in patients with advanced esophageal cancer. PFS is defined as the time from first medication to disease progression or death, whichever is earlier
Measured: for 4 months following the date the last patient was randomized
Disease Control Rate
The study is designed to evaluate the disease control rate of HR070803 in patients with advanced esophageal cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD)
Measured: for 4 months following the date the last patient was randomized
Duration of Response
The study is designed to evaluate the duration of response of HR070803 in patients with advanced esophageal cancer. DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.
Measured: for 4 months following the date the last patient was randomized
Overall Survival
The study is designed to evaluate the overall survival of HR070803 in patients with advanced esophageal cancer. OS is defined as the time from first medication to death of any cause, censored for patients alive at data cut-off.
Measured: for 6 months following the date the last patient was randomized
Number of Patients with Adverse Events as Assessed by NCI-CTCAE V5.0
Safety and tolerability will consist of monitoring and recording all AEs and SAEs as characterized by type, incidence, severity, and the relationship to the study therapy. AEs will be evaluated for all treated patients using NCI-CTCAE V5.0.
Measured: for 6 months following the date the last patient was randomized
ECOG Score for performance status
Measured: for 6 months following the date the last patient was randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start27 Jul 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Mar 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 Jiangsu HengRui Medicine Co., Ltd.The 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
- Model description
- HR070803 for all enrolled subjects
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425472
- Sponsor's protocol ID
- HR070803-201
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 6 Sep 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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05425472
- Acronym / sponsor ID
- HR070803-201
- Conditions
- Advanced Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 21 Jun 2022 (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 efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HR070803 for all enrolled subjects
| Arm | Type | Receives |
|---|---|---|
| HR070803 | Experimental | Drug: HR070803HR070803 monotherapy will be administered by intravenous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECOG performance status 0 or 1
- Histologically confirmed advanced esophageal carcinoma
- At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
- Able and willing to provide a written informed consent
Key exclusion criteria (4 listed)
- The tumor obviously invades adjacent organs of esophageal lesions
- BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening
- Subjects with unresolved adverse effects of prior therapy at the time of enrolment
- Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
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 |
|---|---|---|
| HR070803HR070803 | Drug | HR070803 |
Primary outcome
Objective response rate
Time frame: for 4 months following the date the last patient was randomized
The study is designed to evaluate the objective response rate of HR070803 in patients with advanced esophageal cancer. ORR is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST version 1.1.
6 secondary outcomes
Progression Free Survival
Time frame: for 4 months following the date the last patient was randomized
Disease Control Rate
Time frame: for 4 months following the date the last patient was randomized
Duration of Response
Time frame: for 4 months following the date the last patient was randomized
Overall Survival
Time frame: for 6 months following the date the last patient was randomized
Number of Patients with Adverse Events as Assessed by NCI-CTCAE V5.0
Time frame: for 6 months following the date the last patient was randomized
ECOG Score for performance status
Time frame: for 6 months following the date the last patient was randomized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 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 HR070803 in people with Advanced Esophageal Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 4 inclusion and 4 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 6 Sep 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 Xiaoshuo Zhang (+0518-82342973, xiaoshuo.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: for 4 months following the date the last patient was randomized). 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 6 Sep 2022.