Esophageal Squamous Cell CarcinomaPhase 2NCT03603756
SHR-1210 in Combination With Apatinib and Chemotherapy in Patients With Advanced Esophageal Squamous Cell Cancer
A Phase 2 study testing SHR-1210, Apatinib and Irinotecan Injection in people with Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma are recruited to this prospective non-randomized study comprising two separate cohorts. Patients will receive SHR-1210, a novel anti-PD-1 antibody, with apatinib and either irinotecan or paclitaxel liposome plus nedaplatin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- SHR-1210, Apatinib and Irinotecan Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2018to 28 Mar 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
- Have not received prior systemic therapy.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.
- Life expectancy >12 weeks.
- Adequate organ function.
- For females of child bearing potential, a negative urine or serum pregnancy test result within 72h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study until 2 months after the last dose of any of the drugs in the study.
- Willing and able to provide written informed consent and comply with the requirements of the study.
Who cannot join
- Any previous malignancy, except for non squamous-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix within 5 years prior to study entry.
- Known central nervous system (CNS) metastases.
- Prior therapy with any of the immune check-point inhibitors.
- Known immediate or delayed hypersensitivity reaction to SHR-1210, apatinib, irinotecan, paclitaxel liposome, nedaplatin or their excipients.
- Subjects with any active autoimmune disease or history of autoimmune disease.
- Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C infection.
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- Concurrent medical condition requiring the use of cortisol (>10mg/day prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids no more than 10 mg/day prednisone or equivalent.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Hypertension with a blood pressure of systolic> 140 millimeter of mercury (mm Hg) and/or diastolic > 90 mm Hg that is not effectively controlled by anti-hypertensive therapy.
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention.
- Unable to swallow oral medications or with gastrointestinal disorders that might interfere with proper absorption of oral drugs.
- Active digestive ulcer disease, inflammatory bowel disease, intestinal obstruction or any other condition that, in the clinical judgment of the Principal Investigator, may cause severe gastrointestinal bleeding or perforation.
- Active infection or an unexplained fever > 38.5°C before 4 weeks of enrollment.
- Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic conditions.
- Pregnant or lactating female.
- Familial, sociological or geographical conditions that, in the clinical judgment of the Principal Investigator, do not permit compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
Jianping Xu, MD contact
About this study
Official title: SHR-1210, a Novel Anti-PD-1 Antibody, in Combination With Apatinib and Irinotecan/Paclitaxel Liposome Plus Nedaplatin in Patients With Previously Untreated Advanced or Metastatic Esophageal Squamous Cell Cancer: a Phase II Study
Patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma are recruited to this prospective non-randomized study comprising two separate cohorts. Patients will receive SHR-1210, a novel anti-PD-1 antibody, with apatinib and either irinotecan or paclitaxel liposome plus nedaplatin. The primary endpoint is to determine the objective response rate (ORR) of patients in both cohorts. The regimen(s) of promising efficacy will be further verified in subsequent randomized studies to define the optimal combination of immunotherapy, anti-angiogenesis and chemotherapy in advanced esophageal cancer patients.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- SHR-1210, Apatinib, Irinotecan Injection, Paclitaxel liposome, Nedaplatin
- 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-1210Drug
a novel anti-PD-1 antibody
ApatinibDrug
a VEGFR-2 tyrosine kinase inhibitor
Irinotecan InjectionDrug
cytotoxic agent that binds to topoisomerase I
Paclitaxel liposomeDrug
cytotoxic agent that prevent depolymerization of cellular microtubules
NedaplatinDrug
cytotoxic agent that cross-links and denatures strands of DNA
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients with advanced or metastatic esophageal squamous cell carcinoma are to receive SHR-1210 with apatinib and irinotecan injection in cohort 1. Receives: Drug: SHR-1210; Drug: Apatinib; Drug: Irinotecan Injection |
| Cohort 2 | Experimental | Patients with advanced or metastatic esophageal squamous cell carcinoma are to receive SHR-1210 with apatinib and paclitaxel liposome plus nedaplatin in cohort 2. Receives: Drug: SHR-1210; Drug: Apatinib; Drug: Paclitaxel liposome; Drug: Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
objective response rate of the patients in cohort 1 and cohort 2
Measured: 24 months
Secondary outcomes (3)
progression-free survival (PFS)
progression-free survival (PFS) of the patients in cohort 1 and cohort 2
Measured: 24 months
overall survival
overall survival of the patients in cohort 1 and cohort 2
Measured: 24 months
treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start31 Jul 2018
- Primary completion28 Mar 2020 (estimated)
- Study completion28 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Huang, Chinese Academy of Medical Sciences
- Investigators
- Jing Huang, MD, Principal investigator, Cancer Hospital,CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603756
- Sponsor's protocol ID
- NCC201807010
- Status last verified
- Feb 2020
- First submitted
- 20 Jul 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang B, Qi L, Wang X, Xu J, Liu Y, Mu L, Wang X, Bai L, Huang J. Phase II clinical trial using camrelizumab combined with apatinib and chemotherapy as the first-line treatment of advanced esophageal squamous cell carcinoma. Cancer Commun (Lond). 2020 Dec;40(12):711-720. doi: 10.1002/cac2.12119. Epub 2020 Dec 12.
PubMed 33314747
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR-1210, a Novel Anti-PD-1 Antibody, in Combination With Apatinib and Irinotecan/Paclitaxel Liposome Plus Nedaplatin in Patients With Previously Untreated Advanced or Metastatic Esophageal Squamous Cell Cancer: a Phase II Study
- ClinicalTrials.gov ID
- NCT03603756
- Acronym / sponsor ID
- NCC201807010
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 28 Mar 2020 (estimated)
- Study completion
- 28 Mar 2021 (estimated)
- First posted
- 27 Jul 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.
Patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma are recruited to this prospective non-randomized study comprising two separate cohorts. Patients will receive SHR-1210, a novel anti-PD-1 antibody, with apatinib and either irinotecan or paclitaxel liposome plus nedaplatin. The primary endpoint is to determine the objective response rate (ORR) of patients in both cohorts. The regimen(s) of promising efficacy will be further verified in subsequent randomized studies to define the optimal combination of immunotherapy, anti-angiogenesis and chemotherapy in advanced esophageal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SHR-1210, Drug: Apatinib, Drug: Irinotecan InjectionPatients with advanced or metastatic esophageal squamous cell carcinoma are to receive SHR-1210 with apatinib and irinotecan injection in cohort 1. |
| Cohort 2 | Experimental | Drug: SHR-1210, Drug: Apatinib, Drug: Paclitaxel liposome, Drug: NedaplatinPatients with advanced or metastatic esophageal squamous cell carcinoma are to receive SHR-1210 with apatinib and paclitaxel liposome plus nedaplatin in cohort 2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
- Have not received prior systemic therapy.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.
- Life expectancy >12 weeks.
Key exclusion criteria (16 listed)
- Any previous malignancy, except for non squamous-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix within 5 years prior to study entry.
- Known central nervous system (CNS) metastases.
- Prior therapy with any of the immune check-point inhibitors.
- Known immediate or delayed hypersensitivity reaction to SHR-1210, apatinib, irinotecan, paclitaxel liposome, nedaplatin or their excipients.
- Subjects with any active autoimmune disease or history of autoimmune disease.
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-1210a novel anti-PD-1 antibody | Drug | Cohort 1, Cohort 2 |
| Apatiniba VEGFR-2 tyrosine kinase inhibitor | Drug | Cohort 1, Cohort 2 |
| Irinotecan Injectioncytotoxic agent that binds to topoisomerase I | Drug | Cohort 1 |
| Paclitaxel liposomecytotoxic agent that prevent depolymerization of cellular microtubules | Drug | Cohort 2 |
| Nedaplatincytotoxic agent that cross-links and denatures strands of DNA | Drug | Cohort 2 |
Primary outcome
objective response rate
Time frame: 24 months
objective response rate of the patients in cohort 1 and cohort 2
3 secondary outcomes
progression-free survival (PFS)
Time frame: 24 months
overall survival
Time frame: 24 months
treatment-related adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 33314747Zhang B, Qi L, Wang X, Xu J, Liu Y, Mu L, Wang X, Bai L, Huang J. Phase II clinical trial using camrelizumab combined with apatinib and chemotherapy as the first-line treatment of advanced esophageal squamous cell carcinoma. Cancer Commun (Lond). 2020 Dec;40(12):711-720. doi: 10.1002/cac2.12119. Epub 2020 Dec 12.
- 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.
Jianping Xu, MD contact
Jing Huang, MD principal investigator
Cancer Hospital,CAMS
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-1210, Apatinib and Irinotecan Injection in people with Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences 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 8 inclusion and 16 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 11 Feb 2020. 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 Jing Huang, MD (86-10-87788102, huangjingwg@163.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: 24 months). 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 NCT03603756, which also lists 1 linked publication.
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 11 Feb 2020.