Esophageal Squamous Cell CarcinomaPhase 2NCT04866381
An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
A Phase 2 study testing SHR-6390, SHR-6390 + Camrelizumab (SHR-1210) and Camrelizumab (SHR-1210) + SHR-1020 in people with Esophageal Squamous Cell Carcinoma and Progression to PD-1 Antibody, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Progression to PD-1 Antibody
- What is being tested?
- SHR-6390, SHR-6390 + Camrelizumab (SHR-1210) and Camrelizumab (SHR-1210) + SHR-1020
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- Apr 2021to Apr 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
- Patients who were diagnosed as esophageal squamous cell carcinoma by histopathology with at least one measurable lesion according to RECIST 1.1 criteria.
- Must have had progressive disease after previous treatment with PD-1 inhibitor
- ECOG score 0-2
- The expected survival time is ≥ 12 weeks
- Previous permanent discontinuation did not occur due to adverse events associated with immunotherapy, or the immunotreatment-related adverse events recovered to ≤1 grade
Who cannot join
- Had other active malignant tumors within 5 years before entering the study
- Had abnormal swallowing function or dysfunction of gastrointestinal absorption
- The first study drug treatment was less than 28 days or 5 half-lives (in terms of longer) from the last radiotherapy, chemotherapy, targeted therapy or immunotherapy
- Patients who have already received surgery within 28 days (biopsy for diagnosis is permitted)
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Qingsong Pang, MD, +86-22-23340123-1121, pangqingsong@tjmuch.com
Ting Deng, MD, +86-22-23340123-1051, xymcdengting@126.com
About this study
This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.
- Being tested
- SHR-6390, SHR-6390 + Camrelizumab (SHR-1210), Camrelizumab (SHR-1210) + SHR-1020
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-6390Drug
SHR-6390
SHR-6390 + Camrelizumab (SHR-1210)Drug
SHR-6390 combined with Camrelizumab (SHR-1210)
Camrelizumab (SHR-1210) + SHR-1020Drug
Camrelizumab (SHR-1210) combined with SHR-1020
| Study group | Role | What they receive |
|---|---|---|
| SHR-6390 | Experimental | SHR-6390 Receives: Drug: SHR-6390 |
| SHR-6390 combined with Camrelizumab (SHR-1210) | Experimental | SHR-6390 combined with Camrelizumab (SHR-1210) Receives: Drug: SHR-6390 + Camrelizumab (SHR-1210) |
| Camrelizumab (SHR-1210) combined with SHR-1020 | Experimental | Camrelizumab (SHR-1210) combined with SHR-1020 Receives: Drug: Camrelizumab (SHR-1210) + SHR-1020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria.
Measured: 1 year
Secondary outcomes (3)
Progression-Free-Survival
Progression-Free-Survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first.
Measured: Up to 1 year
Overall survival
Overall survival is defined as time from treatment start date to date of death from any cause. Patients alive at the time of analysis are censored at last contact date.
Measured: Up to 1 year
Subject safety
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866381
- Sponsor's protocol ID
- CIH-PQS-20210408
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
- ClinicalTrials.gov ID
- NCT04866381
- Acronym / sponsor ID
- CIH-PQS-20210408
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 29 Apr 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 is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-6390 | Experimental | Drug: SHR-6390SHR-6390 |
| SHR-6390 combined with Camrelizumab (SHR-1210) | Experimental | Drug: SHR-6390 + Camrelizumab (SHR-1210)SHR-6390 combined with Camrelizumab (SHR-1210) |
| Camrelizumab (SHR-1210) combined with SHR-1020 | Experimental | Drug: Camrelizumab (SHR-1210) + SHR-1020Camrelizumab (SHR-1210) combined with SHR-1020 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who were diagnosed as esophageal squamous cell carcinoma by histopathology with at least one measurable lesion according to RECIST 1.1 criteria.
- Must have had progressive disease after previous treatment with PD-1 inhibitor
- ECOG score 0-2
- The expected survival time is ≥ 12 weeks
- Previous permanent discontinuation did not occur due to adverse events associated with immunotherapy, or the immunotreatment-related adverse events recovered to ≤1 grade
Key exclusion criteria (5 listed)
- Had other active malignant tumors within 5 years before entering the study
- Had abnormal swallowing function or dysfunction of gastrointestinal absorption
- The first study drug treatment was less than 28 days or 5 half-lives (in terms of longer) from the last radiotherapy, chemotherapy, targeted therapy or immunotherapy
- Patients who have already received surgery within 28 days (biopsy for diagnosis is permitted)
- Pregnant or lactating women
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 |
|---|---|---|
| SHR-6390SHR-6390 | Drug | SHR-6390 |
| SHR-6390 + Camrelizumab (SHR-1210)SHR-6390 combined with Camrelizumab (SHR-1210) | Drug | SHR-6390 combined with Camrelizumab (SHR-1210) |
| Camrelizumab (SHR-1210) + SHR-1020Camrelizumab (SHR-1210) combined with SHR-1020 | Drug | Camrelizumab (SHR-1210) combined with SHR-1020 |
Primary outcome
Objective Response Rate
Time frame: 1 year
Objective Response Rate is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria.
3 secondary outcomes
Progression-Free-Survival
Time frame: Up to 1 year
Overall survival
Time frame: Up to 1 year
Subject safety
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Esophageal Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
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 SHR-6390, SHR-6390 + Camrelizumab (SHR-1210) and Camrelizumab (SHR-1210) + SHR-1020 in people with Esophageal Squamous Cell Carcinoma and Progression to PD-1 Antibody, run by Tianjin Medical University Cancer Institute and 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 5 inclusion and 5 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 29 Apr 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 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 29 Apr 2021.