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Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer
Plain-language guide to NCT07780721: phase 2 interventional trial of Thymosin Alpha-1, 31 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07780721
- Phase
- phase 2
- Status
- not yet recruiting
- Start
- 2026-08-30
- Completion (planned or actual)
- 2028-08-01
- Participants
- 31 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Esophageal Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Thymosin Alpha-1.
This is a prospective, single-arm, multicenter clinical study conducted in China.
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).
It had 1 arm (groups): Treatment Arm (Adebrelimab + Thymalfasin + Chemotherapy Neoadjuvant Regimen) (experimental).
All eligible patients receive neoadjuvant therapy for 2-3 cycles (3 weeks per cycle), followed by radical esophagectomy with lymph node dissection.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 31 planned participants were the target.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Has signed the written informed consent form and voluntarily participates in this study;. Aged 18-80 years, male or female;. Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;. Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;. Expected to achieve R0 resection;.
The full record lists 16 inclusion and 18 exclusion criteria; among the exclusions: tumor invades adjacent organs of the esophageal lesion (major arteries or trachea);; uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;; history of allergy to any component of monoclonal antibodies, adebrelimab, thymalfasin, paclitaxel, carboplatin or other platinum agents;.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Thymosin Alpha-1 study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2026-08-30 with completion listed for 2028-08-01.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Pathologic Complete Response (pCR) Rate (time frame: 2 weeks after surgery).
It also tracked 6 secondary outcomes, for example R0 Resection Rate, Major Pathologic Response (MPR)Rate, Disease-Free Survival(DFS), Objective Response Rate(ORR), Overall Survival(OS) and Incidence and Grade of Adverse Events and Serious Adverse Events [Safety and Tolerability].
What This Means in Plain Language
Put simply, this is a phase 2 trial of Thymosin Alpha-1 in 31 people.
Its size is small, so on its own it can only give an early look.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Thymosin Alpha-1 compound page, all human trials.
Our Notes on the Compound
Thymosin Alpha-1: An immune-modulating thymic peptide that recalibrates T-cell function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.