The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Location contact
Jun Wang
CONTACT
Jun Wang
PRINCIPAL_INVESTIGATOR
Zhiguo Zhou
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07112833
This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT or RECIST1.1 assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Shijiazhuang, Hebei, 050000, China
Jun Wang
CONTACT
Jun Wang
PRINCIPAL_INVESTIGATOR
Zhiguo Zhou
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Induction stage:Adebrelimab+TC: Adebrelimab : 1200mg d1, iv, q3w ; TC : paclitaxel 135mg/m2, or nab-paclitaxel paclitaxel 180mg/m2, d1, iv,carboplatin AUC=5, d1, iv, q3w,2 cycles.
Treatment stage: TC/PF+ radiation therapy:
PET-CT responders (SUV (PETr) reduction ≥35%):
TC/PF+ radiation therapy:
TC : paclitaxel 50mg/m2, nab-paclitaxel paclitaxel 60mg/m2, d1, iv; carboplatin AUC=2, d1, iv, qw,5 cycles.
PF : fluorouracil 750-1000mg/m2, CIV 96 hours,cisplatin 75mg/m2, d1, iv, q4w,2 cycles.
Radiation therapy: 50.4Gy-60Gy/28-33f.
PET-CT non-responders (SUV (PETr) reduction <35%):(switch to a different chemotherapy drug which not used during the earlier induction phase)
PF/TC+ radiation therapy:
dose same as above.
Maintenance stage: Adebrelimab:
Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs(Up to one year).
Time frame: 12 months
PFS defined as the time from the date of treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
Time frame: 12 months
A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions.
Time frame: 12 months
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Time frame: 12 months
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
Time frame: 12 months
Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause.
Time frame: 24 months
PFS defined as the time from the date of treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
Time frame: 24 months
Defined as the time between signing the informed consent form to death due to various causes.
Time frame: 24 months
Use NCI-CTCAE version 5.0 for classification and grading.
Hebei Medical University Fourth Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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