Advanced Esophageal CancerPhase 3NCT03691090
Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer
A Phase 3 study testing SHR-1210, paclitaxel and cisplatin in people with Advanced 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 SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. 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?
- SHR-1210, paclitaxel and cisplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 596 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2018to 30 Apr 2022
- 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
- Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
- No previous systemic anti-tumor treatment;
- Subjects must have at least one measurable tumor lesion per RECIST 1.1;
- Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
- ECOG: 0-1;
- Adequate organ and bone marrow function;
Who cannot join
- Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
- Prior therapy as follow:
- Anti-PD-1 or anti-PD-L1;
- Any experimental drugs within 4 weeks of the first dose of study medication;
- Received major operations or serious injuries within 4 weeks of the first dose of study medication;
- Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
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- Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
- Subjects with any active autoimmune disease or history of autoimmune disease;
- Pregnancy or breast feeding;
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Center of Sun-Yat Sen University (CCSYSU)
Guangzhou, Guangdong, 510060
About this study
Official title: PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. 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. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.
- Conditions
- Advanced Esophageal Cancer
- Being tested
- SHR-1210, Placebo, paclitaxel, cisplatin
- Keywords
- PD-1Antibody, advanced esophageal cancer, paclitaxel, cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Drug
Also called camrelizumab
SHR-1210 200mg
PlaceboDrug
Placebo
paclitaxelDrug
paclitaxel 175mg/m2
cisplatinDrug
cisplatin 75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 + paclitaxel + cisplatin | Experimental | Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance Receives: Drug: SHR-1210; Drug: paclitaxel; Drug: cisplatin |
| placebo+paclitaxel + cisplatin | Active comparator | Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance Receives: Drug: Placebo; Drug: paclitaxel; Drug: cisplatin |
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: approximately 22 months
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: approximately 22 months
Secondary outcomes (6)
PFS assessed by investigators
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: approximately 22 months
6 and 9 month OS rate
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: approximately 6 and 9 months
ORR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: approximately 22 months
DCR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: approximately 22 months
DoR
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: approximately 22 months
AE
adverse events
Measured: approximately 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start3 Dec 2018
- Primary completion30 Oct 2020
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, Principal investigator, Cancer Center of Sun-Yat Sen University (CCSYSU)Qing Yang, Study director, Jiangsu HengRui Medicine Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691090
- Sponsor's protocol ID
- SHR-1210-III-306
- Status last verified
- Jun 2022
- First submitted
- 21 Sep 2018
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.
PubMed 37139963Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.
PubMed 34519801
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial
- ClinicalTrials.gov ID
- NCT03691090
- Acronym / sponsor ID
- SHR-1210-III-306
- Conditions
- Advanced Esophageal Cancer
- Keywords
- PD-1Antibody, advanced esophageal cancer, paclitaxel, cisplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 1 Oct 2018 (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 SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. 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. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) 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 |
|---|---|---|
| SHR-1210 + paclitaxel + cisplatin | Experimental | Drug: SHR-1210, Drug: paclitaxel, Drug: cisplatinPaclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance |
| placebo+paclitaxel + cisplatin | Active comparator | Drug: Placebo, Drug: paclitaxel, Drug: cisplatinPaclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
- No previous systemic anti-tumor treatment;
- Subjects must have at least one measurable tumor lesion per RECIST 1.1;
- Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
- ECOG: 0-1;
Key exclusion criteria (9 listed)
- Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
- Prior therapy as follow:
- Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
- Subjects with any active autoimmune disease or history of autoimmune disease;
- Pregnancy or breast feeding;
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-1210Also: camrelizumabSHR-1210 200mg | Drug | SHR-1210 + paclitaxel + cisplatin |
| PlaceboPlacebo | Drug | placebo+paclitaxel + cisplatin |
| paclitaxelpaclitaxel 175mg/m2 | Drug | SHR-1210 + paclitaxel + cisplatin, placebo+paclitaxel + cisplatin |
| cisplatincisplatin 75mg/m2 | Drug | SHR-1210 + paclitaxel + cisplatin, placebo+paclitaxel + cisplatin |
Primary outcome
PFS assessed by IRC
Time frame: approximately 22 months
based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
OS
Time frame: approximately 22 months
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.
6 secondary outcomes
PFS assessed by investigators
Time frame: approximately 22 months
6 and 9 month OS rate
Time frame: approximately 6 and 9 months
ORR
Time frame: approximately 22 months
DCR
Time frame: approximately 22 months
DoR
Time frame: approximately 22 months
AE
Time frame: approximately 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 37139963Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.
- Derived from this study: PubMed 34519801Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.
- 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.
Ruihua Xu principal investigator
Cancer Center of Sun-Yat Sen University (CCSYSU)
Qing Yang study director
Jiangsu HengRui Medicine Co., Ltd.
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 SHR-1210, paclitaxel and cisplatin 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 7 Dec 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: approximately 22 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691090, which also lists 2 linked publications.
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 7 Dec 2022.