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Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell Cancer

NCT04654403 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2021-08-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Camrelizumab or Camrelizumab plus chemotherapy in patients with untreated, advanced ESCC with PD-L1 CPS≥10 ,who have been achieved PR and CR after treated with Camrelizumab.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Camrelizumab

Eligible patients receive Camrelizumab 200 mg by intravenous (iv.) infusion every 2 weeks (Q2W) for 4 cycles.Imaging will be performed 2-3 weeks after the 4th Camrelizumab administration.Patients who achieve PD and SD will be not included in the data statistics of this trial.The follow-up treatment according to investigator's and patients's choice(chemotherapy, Camrelizumab plus chemotherapy or Camrelizumab monotherapy).Other patients whose BOR is in remission (CR+PR) will be randomly assigned in a 1:1 ratio to receive Camrelizumab (200 mg every 2 weeks), or Camrelizumab plus chemotherapy(Camrelizumab 200 mg every 3 weeks,docetaxel 75mg/m2/d plus cisplatin 75 mg/m2/d on day 1 every 3 weeks),)Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, nonadherence to treatment or trial procedures or completion of 16 cycles of Camrelizumab (approximately 1 years).

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Principal Investigators

  • Feng Wang, Doctor · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-05-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654403 on ClinicalTrials.gov