NCT03603756

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2021

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

July 20, 2018

Last Update Submit

February 9, 2020

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    objective response rate of the patients in cohort 1 and cohort 2

    24 months

Secondary Outcomes (3)

  • progression-free survival (PFS)

    24 months

  • overall survival

    24 months

  • treatment-related adverse events

    24 months

Study Arms (2)

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.

Drug: SHR-1210Drug: ApatinibDrug: 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.

Drug: SHR-1210Drug: ApatinibDrug: Paclitaxel liposomeDrug: Nedaplatin

Interventions

SHR-1210DRUG

a novel anti-PD-1 antibody

Cohort 1Cohort 2
ApatinibDRUG

a VEGFR-2 tyrosine kinase inhibitor

Cohort 1Cohort 2
Irinotecan InjectionDRUG

cytotoxic agent that binds to topoisomerase I

Cohort 1
Paclitaxel liposomeDRUG

cytotoxic agent that prevent depolymerization of cellular microtubules

Cohort 2
NedaplatinDRUG

cytotoxic agent that cross-links and denatures strands of DNA

Cohort 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jing Huang

Beijing, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33314747DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

camrelizumabapatinibIrinotecannedaplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Jing Huang, MD

    Cancer Hospital,CAMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Huang, MD

CONTACT

86-10-87788102huangjingwg@163.com

Jianping Xu, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2018

First Posted

July 27, 2018

Study Start

July 31, 2018

Primary Completion

March 28, 2020

Study Completion

March 28, 2021

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)