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A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma

NCT06753747 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Afatinib plus Palbociclib works in previously treated recurrent or metastatic esophageal squamous cell carcinoma. It will also learn about the safety of the combination of Afatinib and Palbociclib. The main questions it aims to answer are:

What is the safe and tolerable dose of Afatinib when combined with 100 mg of Palbociclib (administered orally, three weeks on and one week off)?

Does the combination therapy of Afatinib and Palbociclib induce a tumor response in patients with recurrent or metastatic esophageal squamous cell carcinoma who have received prior treatments?

Conditions

  • Esophagus Cancer

Interventions

DRUG

Palbociclib

Palbociclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle.

DRUG

Afatinib(30mg)

Afatinib will be administered orally at a dose of 30 mg once daily (QD) in each 4-week cycle.

DRUG

Afatinib(40mg)

Afatinib will be administered orally at a dose of 40 mg once daily (QD) in each 4-week cycle.

DRUG

Afatinib(RP2D)

In the Phase 2 study, the recommended Phase 2 dose (RP2D) of Afatinib, determined during the Phase 1b portion, will be utilized.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Jin Zhou · West China Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2027-09-30
Completion
2028-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06753747 on ClinicalTrials.gov