Trial · Interventional
Not yet recruitingPhase 2Registry dataStudy of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer
Overview
- Status
- Not yet recruiting
- Phase
- Phase 2
- Enrollment
- 31 participants (estimated)
- Sponsor
- The Affiliated Hospital of Putian University · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
China
- Start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Completion
- 1 Feb 2029 (estimated)
- First posted
- 21 Aug 2026
- Last update posted
- 21 Aug 2026
- Conditions
- Esophageal Cancer
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer
NCT07780721est. 30 Aug 2026 to est. 1 Feb 2029
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma. The study consists of a screening period (from the signing of informed consent by subjects to the first study drug administration, no more than 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (comprising safety follow-up and survival follow-up). During neoadjuvant therapy, patients will receive 2 to 3 cycles of adebrelimab combined with thymalfasin and chemotherapy, followed by surgical resection.
Interventions
- AdebrelimabDrug
- ThymalfasinDrug
- ChemotherapyDrug
Arms1
Experimental
Treatment Arm (Adebrelimab + Thymalfasin + Chemotherapy Neoadjuvant Regimen)
All eligible patients receive neoadjuvant therapy for 2-3 cycles (3 weeks per cycle), followed by radical esophagectomy with lymph node dissection.
Primary outcomes1
Outcomes the sponsor listed as primary.
Pathologic Complete Response (pCR) Rate
Time frame · 2 weeks after surgery
Registry description
Defined as the proportion of subjects with Grade I pathological response per the pathological response evaluation criteria after neoadjuvant therapy, i.e., no residual viable tumor in the primary tumor lesion.
Secondary outcomes(6)
R0 Resection Rate
Time frame · 2 weeks after surgery
Registry description
No residual viable tumor cells at the surgical resection margins
Major Pathologic Response (MPR)Rate
Time frame · 2 weeks after surgery
Registry description
Defined as the percentage of subjects with ≤10% residual viable tumor (Grade I and Grade II pathological response).
Disease-Free Survival(DFS)
Time frame · Defined as the time from the date of surgery (the first disease-free day) to local or distant disease recurrence, or death from any cause, whichever occurs first.Assessed for a maximum of 60 months.
Registry description
Defined as the time from the date of surgery (the first disease-free day) to local or distant disease recurrence, or death from any cause, whichever occurs first.
Objective Response Rate(ORR)
Time frame · At the end of Cycle 2-3 (each cycle is 21 days)
Registry description
Defined as the proportion of subjects achieving complete response (CR) or partial response (PR) based on imaging assessments performed from study enrollment to prior to surgery, evaluated per RECIST version 1.1 criteria.
Overall Survival(OS)
Time frame · From date of first study drug administration until death from any cause, assessed up to study completion。Assessed for a maximum of 60 months.
Registry description
Defined as the time from the date of first study drug administration to death from any cause.
Incidence and Grade of Adverse Events and Serious Adverse Events [Safety and Tolerability]
Time frame · From informed consent signature through 90 days after the last dose of adebrelimab
Registry description
Assessed according to NCI-CTCAE Version 5.0 criteria
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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