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A Prospective, Randomized, Open, Phase II Clinical Study of Chidamide in Combination with Camrelizumab and Apatinib for Advanced Esophageal Cancer

ConditionAdvanced Esophageal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University

About this trial

This study aims to evaluate the efficacy and safety of a combination treatment of chidamide, camrelizumab, and apatinib in patients with advanced esophageal cancer. This open-label, phase II clinical trial will involve randomly assigning participants to receive either the combination of these drugs or a standard treatment. The primary endpoints is ORR and the second endpoints include progression-free survival and overall survival, while safety will also be assessed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • chidamide+Camrelizumab+Apatinib

    Drug

    chidamide+Camrelizumab+Apatinib

  • Irinotecan or Docetaxel or Paclitaxel

    Drug

    Irinotecan Docetaxel Paclitaxel

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: chidamide+Camrelizumab+ApatinibExperimental treatment 1 intervention
Group B: SOCPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate（ORR）

Time frame
up to 24 months

Secondary outcomes

1

progression free surival（PFS）

Time frame
up to 24 months
2

overall surival（OS）

Time frame
up to 24 months
3

Adverse events

Time frame
up to 24 months
4

Disease Control Rate（DCR）

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: