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Esophagus CancerPhase 1/2NCT06753747

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

A Phase 1/2 study testing Palbociclib, Afatinib(30mg) and Afatinib(40mg) in people with Esophagus Cancer, run by West China Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophagus Cancer
What is being tested?
Palbociclib, Afatinib(30mg) and Afatinib(40mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
10 Sep 2025to Sep 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 years
  • Histologically or cytologically confirmed as ESCC, locally advanced and unresectable, with local recurrence (local lymph node metastases) or distant metastases
  • Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification (EGFR expression is not required in Phase 1b, but only patients with EGFR overexpression will be included in Phase 2).
  • Disease progression after first-line or subsequent lines of therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Adequate organ function within 7 days prior to treatment initiation, meeting the following criteria:Hematology (without transfusion, blood products, or administration of G-CSF or other hematopoietic stimulants within the past 14 days):
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  • Hemoglobin (Hb) ≥ 90 g/L;
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
  • Platelet count (PLT) ≥ 75 × 10⁹/L.
  • Serum biochemistry:
  • Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN;
  • Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60 mL/min. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, as assessed by Doppler ultrasound.
  • Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
  • Female patients of childbearing potential must agree to use appropriate contraception from screening until 3 months after the end of treatment and must not be breastfeeding. A negative pregnancy test is required within 7 days before the start of treatment. Male patients must agree to use appropriate contraception or have undergone surgical sterilization during the study and for 8 weeks after the last administration of study medication.
  • All subjects are recruited on a voluntary basis and sign the informed consent. They are required to be compliant with the study and cooperative with the follow-up.

Who cannot join

  • Patients who have a history of other malignancies in the past five years (except for the cured basal cell carcinoma and cervical carcinoma in situ)
  • The patient has any active autoimmune disease or a history of autoimmune disease
  • History of severe allergic reactions or known allergies to macromolecular protein preparations, Afatinib, Palbociclib, or any component of their formulations that have resulted in hospitalization.
  • Presence of contraindications to Palbociclib or Afatinib.
  • Previous or planned treatments as follows:
  • Prior use of EGFR inhibitors or CDK4/6 inhibitors.
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  • Administration of any live vaccines (e.g., influenza or varicella vaccines) within 4 weeks before the first dose or during the study.
  • Major surgery or significant trauma within 4 weeks before the first dose.
  • Residual toxicities from prior anti-tumor therapies not resolved to ≤ Grade 1 per CTCAE v5.0, except for alopecia or platinum-based therapy-induced neuropathy.
  • Severe medical conditions, such as:
  • NYHA Class II or higher heart failure.
  • Ischemic heart disease (e.g., myocardial infarction or angina).
  • Clinically significant supraventricular or ventricular arrhythmias.
  • Poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L).
  • Poorly controlled hypertension (systolic BP > 150 mmHg and/or diastolic BP > 100 mmHg).
  • Left ventricular ejection fraction (LVEF) < 50% on echocardiography.
  • QTc interval > 450 ms in males or > 470 ms in females.
  • Abnormal ECG findings deemed to pose additional risk by the investigator.
  • Active infections or unexplained fever within 48 hours prior to the first dose, or systemic antibiotic use within one week prior to informed consent.
  • Active hepatitis B (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL), hepatitis C (anti-HCV antibody positive with detectable HCV RNA), known HIV positivity, or acquired immunodeficiency syndrome (AIDS).
  • Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
  • Pregnancy or lactation.
  • Receipt of any investigational drug within 4 weeks before the first dose or concurrent enrollment in another clinical trial, except for observational (non-interventional) studies or interventional trials in follow-up.
  • Any other factors deemed by the investigator to potentially interfere with study participation, including the ability to complete study treatment and follow-up.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jin Zhou contact

+86-13880626596

zhoujin096@scu.edu.cn

China1 site, 1 recruiting

  • West China Hospital

    Chengdu, Sichuan, 610041

    Jin Zhou, +86-13880626596, zhoujin096@scu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 1b/2 Trial of Afatinib Plus Palbociclib in Previously Treated Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

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?

Being tested
Palbociclib, Afatinib(30mg), Afatinib(40mg), Afatinib(RP2D)
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    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.

  • Afatinib(30mg)Drug

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

  • Afatinib(40mg)Drug

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

  • Afatinib(RP2D)Drug

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

Study groups in NCT06753747
Study groupRoleWhat they receive
Phase 1b: Afatinib(30mg)+PalbociclibExperimentalIn phase 1b, there is 2 dose levels for Afatinib, 30mg qd and 40 mg qd, and if no patients experience DLT on 30mg level, 40mg level will be administered.
Receives: Drug: Palbociclib; Drug: Afatinib(30mg)
Phase 1b: Afatinib(40mg)+PalbociclibExperimentalIn phase 1b, there is 2 dose levels for Afatinib, 30mg qd and 40 mg qd, and if no patients experience DLT on 30mg level, 40mg level will be administered.
Receives: Drug: Palbociclib; Drug: Afatinib(40mg)
Phase 2: Afatinib(RP2D)+PalbociclibExperimentalThe RP2D of Afatinib determined in phase 1b will be administrated in phase 2
Receives: Drug: Palbociclib; Drug: Afatinib(RP2D)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Afatinib

    Measured: from the first dose to within 30 days after the last dose

  2. Objective Response Rate (ORR)

    the proportion of patients with a confirmed complete response or partial response, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: up to 2 years

Secondary outcomes (5)

  1. Incidence of Treatment-Emergent Adverse Events

    Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

    Measured: from the first dose to within 30 days after the last dose

  2. Disease Control Rate (DCR)

    Percentage of patients who achieve partial response (PR) or complete response (CR) or stable disease (SD) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

    Measured: up to 2 years

  3. Progression free survival

    the time from treatment initiation to the first disease progression or death from any cause

    Measured: up to 2 years

  4. Overall survival(OS)

    the time from treatment initiation until death from any reason

    Measured: up to 2 years

  5. Anti-tumor activity by Duration of Response (DOR)

    Calculated as the average length of time between response to treatment and disease progression

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2024
  2. Study start10 Sep 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06753747
Sponsor's protocol ID
2024-143
Status last verified
Nov 2025
First submitted
23 Dec 2024
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Palbociclib, Afatinib(30mg) and Afatinib(40mg) in people with Esophagus Cancer, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin Zhou (+86-13880626596, zhoujin096@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Afatinib (time frame: from the first dose to within 30 days after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06753747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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