Esophageal CancerPhase 3NCT04426955
Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer
A Phase 3 study testing Camrelizumab, Paclitaxel and Cisplatin in people with Esophageal Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. 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, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2020to Dec 2023
- Phase
- Phase 3
- 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
- 1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1; 5.Adequate organ function
Who cannot join
- Indicators of severe malnutrition;
- A history of surgery for esophageal cancer;
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
- Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
- Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
- Active autoimmune diseases or history of autoimmune diseases that may relapse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Camrelizumab (SHR-1210) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.
Read the detailed description
In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.
- Conditions
- Esophageal Cancer
- Being tested
- Camrelizumab, Paclitaxel, Cisplatin, Placebo, Radiation
- Keywords
- PD-1Antibody, locally advanced esophageal cancer
- 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 SHR-1210
IV infusion
PaclitaxelDrug
IV infusion
CisplatinDrug
IV infusion
PlaceboDrug
IV infusion
RadiationRadiation
Concurrent Radiation
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy. Receives: Drug: Camrelizumab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiation |
| Arm B | Placebo comparator | Placebo + Paclitaxel + Cisplatin + Radiotherapy. Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Placebo; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS assessed by IRC
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: up to 3 years
Secondary outcomes (5)
PFS assessed by investigators
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: up to 3 years
OS
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
Measured: up to 3 years
ORR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: up to 3 years
DoR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: up to 3 years
AE
adverse events
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Jun 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (actual)
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
- NCT04426955
- Sponsor's protocol ID
- SHR-1210-III-323
- Status last verified
- Sep 2021
- First submitted
- 9 Jun 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Camrelizumab (SHR-1210) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04426955
- Acronym / sponsor ID
- SHR-1210-III-323
- Conditions
- Esophageal Cancer
- Keywords
- PD-1Antibody, locally advanced esophageal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Jun 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.
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.
Detailed description
In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Camrelizumab, Drug: Paclitaxel, Drug: Cisplatin, Radiation: RadiationCamrelizumb + Paclitaxel + Cisplatin + Radiotherapy. |
| Arm B | Placebo comparator | Drug: Paclitaxel, Drug: Cisplatin, Drug: Placebo, Radiation: RadiationPlacebo + Paclitaxel + Cisplatin + Radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1; 5.Adequate organ function
Key exclusion criteria (6 listed)
- Indicators of severe malnutrition;
- A history of surgery for esophageal cancer;
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
- Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
- Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
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: SHR-1210IV infusion | Drug | Arm A |
| PaclitaxelIV infusion | Drug | Arm A, Arm B |
| CisplatinIV infusion | Drug | Arm A, Arm B |
| PlaceboIV infusion | Drug | Arm B |
| RadiationConcurrent Radiation | Radiation | Arm A, Arm B |
Primary outcome
PFS assessed by IRC
Time frame: up to 3 years
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
5 secondary outcomes
PFS assessed by investigators
Time frame: up to 3 years
OS
Time frame: up to 3 years
ORR
Time frame: up to 3 years
DoR
Time frame: up to 3 years
AE
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Camrelizumab, Paclitaxel and Cisplatin in people with 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 1 inclusion and 6 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 16 Sep 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS assessed by IRC (time frame: up to 3 years). 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 16 Sep 2021.