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Not Yet RecruitingNCT07479628

Neoadjuvant Adebrelimab Plus CRT for Locally Advanced Thymic Carcinoma

A Single-Arm, Prospective, Phase II Trial of Adebrelimab Plus Albumin-Bound Paclitaxel, Cisplatin, and Concurrent Radiotherapy for Neoadjuvant Treatment of Locally Advanced Thymic Carcinoma

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
31 (estimated)
Sponsor
Shanghai Chest Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The goal of this clinical trial (Phase II) is to evaluate the efficacy and safety of neoadjuvant Adebrelimab combined with chemoradiation in patients with locally advanced thymic carcinoma. The main questions it aims to answer are: * Is neoadjuvant therapy with Adebrelimab plus chemoradiation effective? * Is this combination treatment safe and tolerable in this patient population? Participants will: * Receive 2-4 cycles of neoadjuvant Adebrelimab combined with a platinum-based chemotherapy regimen (such as carboplatin plus paclitaxel) and concurrent radiotherapy prior to surgery. * Undergo re-staging imaging to assess tumor response and determine surgical candidacy. * Undergo surgical resection if the tumor is resectable after neoadjuvant treatment. * Receive adjuvant Adebrelimab therapy for up to one year following surgery. * Undergo regular follow-up visits for safety monitoring and survival assessment.

Conditions

Interventions

TypeNameDescription
OTHERadebrelimab plus chemoradiationAll patients will receive 2 cycles of adebrelimab (1200mg, D1, Q1W) in combination with albumin-bound paclitaxel (70mg/m2, D1/D8/D15/D22)plus cisplatin (25mg/m2, D1/D8/D15/D22), and concurrent radiotherapy (40Gy) before surgery. If tumors are resectable after neoadjuvant therapy, surgery will be scheduled. After surgery, patients will receive adjuvant chemotherapy (2 cycles), radiotherapy (20Gy) (except for PCR disease), and adebrelimab for up to 1 year. If tumors are still unresectable after neoadjuvant therapy, patients will receive another 2 cylces of chemotherapy, radiotherapy (20Gy), and adebrelimab for up to 1 year.

Timeline

Start date
2026-04-01
Primary completion
2028-03-01
Completion
2030-03-01
First posted
2026-03-18
Last updated
2026-03-18

Source: ClinicalTrials.gov record NCT07479628. Inclusion in this directory is not an endorsement.

Neoadjuvant Adebrelimab Plus CRT for Locally Advanced Thymic Carcinoma (NCT07479628) · Clinical Trials Directory