Actively Recruiting
A Phase 1b/2 Trial of Afatinib Plus Palbociclib in Previously Treated Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Led by West China Hospital · Updated on 2025-12-03
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Afatinib and Palbociclib in adults with recurrent or metastatic esophageal squamous cell carcinoma who have received prior treatments. The study aims to find the safe and tolerable dose of Afatinib when combined with Palbociclib and to assess whether this combination induces a tumor response. This trial is conducted in phases 1b and 2, focusing on patients with specific EGFR expression or amplification and progression after prior therapies. The treatment involves oral administration of Palbociclib at 100 mg daily for three weeks followed by one week off, forming a four-week cycle. Afatinib is given orally once daily at two possible doses (30 mg or 40 mg) during phase 1b to determine the recommended dose for phase 2. Phase 2 uses the determined dose of Afatinib combined with Palbociclib. Dose-limiting toxicities will guide dose escalation in phase 1b. Participants will undergo evaluations including tumor response and safety monitoring. Primary outcomes include finding the maximum tolerated dose and recommended phase 2 dose of Afatinib, as well as objective tumor response rate over up to two years. Secondary outcomes track adverse events, disease control, progression-free survival, overall survival, and duration of response. The study runs through regular assessments during treatment and follow-up lasting up to two years.
CONDITIONS
Brief Title
A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC), locally advanced and unresectable, with local recurrence or distant metastases
- EGFR overexpression or amplification confirmed by immunohistochemistry, FISH, or sequencing (required for phase 2)
- Disease progression after first-line or later therapies
- ECOG performance status of 0 or 1
- Adequate organ function as defined by specific blood counts, liver and kidney tests, cardiac function, and coagulation parameters
- Women of childbearing potential must use contraception and have a negative pregnancy test before treatment; men must agree to contraception or sterilization during and after the study
- Voluntary consent and willingness to comply with study and follow-up requirements
You will not qualify if you...
- History of other cancers in the past five years except cured basal cell carcinoma or cervical carcinoma in situ
- Active or history of autoimmune disease
- Severe allergic reactions or known allergies to study drugs or components requiring hospitalization
- Contraindications to Palbociclib or Afatinib
- Prior use of EGFR or CDK4/6 inhibitors
- Live vaccines within 4 weeks before or during the study
- Major surgery or significant trauma within 4 weeks before treatment
- Unresolved toxicities from prior therapies above grade 1 except alopecia or neuropathy
- Severe heart conditions, poorly controlled diabetes or hypertension, abnormal heart function or ECG
- Active infections, fever, or recent systemic antibiotic use
- Active hepatitis B or C, HIV, or AIDS
- Pregnancy or breastfeeding
- Recent investigational drug use or participation in another trial except observational or follow-up studies
- Any condition or factor that may interfere with study participation or completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies; repeated 4-week cycles until disease progression or discontinuation
Participants receive oral doses of Afatinib and Palbociclib in repeated 4-week cycles until disease progression or discontinuation.
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
J
Jin Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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