NCT04506138

Brief Summary

This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma

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
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_1

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

August 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

August 11, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

5.4 years

First QC Date

August 5, 2020

Last Update Submit

December 12, 2021

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Pathologic complete remission (PCR)

    12 weeks

  • Major Pathologic Response (MPR)

    12 weeks

Secondary Outcomes (2)

  • Overall Survival (OS)

    5 years

  • Event Free Survival（EFS）

    5 years

Other Outcomes (2)

  • EQ-5D-3L questionnaire

    5 years

  • FACT-E questionnaire

    5 years

Study Arms (1)

Camrelizumab plus Chemotherapy

EXPERIMENTAL
Drug: CamrelizumabDrug: Paclitaxel for Injection (Albumin Bound)Drug: Carboplatin

Interventions

CamrelizumabDRUG

Camrelizumab 200mg D1, D22

Camrelizumab plus Chemotherapy
Paclitaxel for Injection (Albumin Bound)DRUG

Paclitaxel for Injection (Albumin Bound) 100mg/m\^2 D1, D8, D22, D29

Camrelizumab plus Chemotherapy
CarboplatinDRUG

Carboplatin AUC5 D1, D22

Camrelizumab plus Chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological diagnosis of thoracic Esophageal squamous cell carcinoma
  • ECOG performance status 0-1
  • Age 18-75 years
  • Resectable disease, cT2-4aNanyM0 or cT1-3N+M0
  • Life expectancy more than 6 months
  • Use of an effective contraceptive for adults to prevent pregnancy

You may not qualify if:

  • Not suitable for surgery
  • Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC
  • Prior esophageal, gastric, or gastro-esophageal junction surgery
  • Esophageal ulcer, esophageal perforation，chest pain（≥middle level）
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

camrelizumabPaclitaxelInjectionsCarboplatin

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)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDrug Administration RoutesDrug TherapyTherapeuticsCoordination Complexes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Thoracic Surgery Department

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 10, 2020

Study Start

August 11, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)