Esophageal Squamous Cell CarcinomaNCT06420908
Adebrelimab Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)
A study testing Adebrelimab+TP/FP+ radiation therapy and Adebrelimab+FP/TP+ radiation therapy in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital.
Trial summary
This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Adebrelimab+TP/FP+ radiation therapy and Adebrelimab+FP/TP+ radiation therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2024to 30 May 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age 18-75 years old, both men and women; 2.Histopathology confirmed as esophageal squamous cell carcinoma，stage II-IVa：T1N2-3M0，T2-4bN+M0； 3.If technically feasible, all patients are recommended to have local staging determined by endoscopic ultrasound (EUS); The endoscopic examination report or gastrointestinal (GI) clinical records should clearly indicate the T and N stages; Perform PET-CT examination; 4.Except for basal or squamous cell skin cancer, bladder cancer in situ or cervical cancer, there is no history of malignant tumor within 5 years; Patients with malignant tumors who have undergone surgical treatment in the past and those who have survived disease-free for more than 5 years meet the inclusion criteria; 5.Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 6.According to RECIST 1.1, at least one measurable lesion; 7.ECOG: 0~1; 8.Expected survival period ≥ 12 weeks; 9.Major organ function has to meet the following certeria:
- Blood routine examination:
- HB≥90g/L;
- ANC ≥ 1.5 × 109 / L;
- PLT ≥ 100 × 109 / L;
- Biochemical examination:
Show all 9Show fewer
- ALT and AST < 2.5×ULN;
- TBIL ≤ 1.5×ULN;
- Cr ≤ 1.5×ULN; 9. Left ventricular ejection fraction (LVEF) ≥50%; 11. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 12. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Who cannot join
- Previous history of esophageal cancer surgery；
- Higher risk of esophageal perforation or fistula；
- Received systemic immunosuppressive therapy within 14 days prior to the first study medication；
- Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function;
- The patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, enteritis, systemic lupus erythematosus, rheumatoid arthritis; patients with vitiligo, Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 copies/ml or 500IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method)；
Show all 12Show fewer
- Within 6 months, cerebral vascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism) occur;
- History of cardiovascular disease with significant clinical significance, including but not limited to: (1) congestive heart failure (NYHA grade>2); (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 3 months; (4) Any supraventricular arrhythmias or ventricular arrhythmias that require treatment or intervention;
- Severe infections within 4 weeks before study drug administration, or active infection with CTCAE ≥ 2 grade treated with antibiotics within 2 weeks before study drug administration;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- The researchers think inappropriate.
About this study
Official title: Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC): A Prospective, Single-arm, Phase II Clinical Study
This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Adebrelimab+TP/FP+ radiation therapy, Adebrelimab+FP/TP+ radiation therapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab+TP/FP+ radiation therapyDrug
Induction stage：
Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles;
Treatment stage:
TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f);
Consolidation stage:
Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs.
Adebrelimab+FP/TP+ radiation therapyDrug
Induction stage：
Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles;
Treatment stage: (switch to a different chemotherapy drug which not used during the earlier induction phase)
FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f);
Consolidation stage:
Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| PET-CT responders | Experimental | SUV (PETr) reduction >35% Receives: Drug: Adebrelimab+TP/FP+ radiation therapy |
| PET-CT non-responders | Experimental | SUV (PETr) reduction ≤35% Receives: Drug: Adebrelimab+FP/TP+ radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Baseline to measured date of progression or death from any cause
Measured: evaluated in 24 months since the treatment began
Secondary outcomes (4)
1. Objective response rate (ORR)
Baseline to measured stable disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 monthss
2. Duration of Overall Response（DoR）
The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 months
3. Overall survival (OS)
Baseline to measured date of death from any cause
Measured: the first day of treatment to death or last survival confirm date,up to 24 months
4. Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start30 May 2024 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2027 (estimated)
Why it stopped: The primary reason for termination was difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun wang, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420908
- Sponsor's protocol ID
- ARL-ESCC-001
- Status last verified
- Aug 2025
- First submitted
- 15 May 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC): A Prospective, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06420908
- Acronym / sponsor ID
- ARL-ESCC-001
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The primary reason for termination was difficulty in recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET-CT responders | Experimental | Drug: Adebrelimab+TP/FP+ radiation therapySUV (PETr) reduction >35% |
| PET-CT non-responders | Experimental | Drug: Adebrelimab+FP/TP+ radiation therapySUV (PETr) reduction ≤35% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Age 18-75 years old, both men and women; 2.Histopathology confirmed as esophageal squamous cell carcinoma，stage II-IVa：T1N2-3M0，T2-4bN+M0； 3.If technically feasible, all patients are recommended to have local staging determined by endoscopic ultrasound (EUS); The endoscopic examination report or gastrointestinal (GI) clinical records should clearly indicate the T and N stages; Perform PET-CT examination; 4.Except for basal or squamous cell skin cancer, bladder cancer in situ or cervical cancer, there is no history of malignant tumor within 5 years; Patients with malignant tumors who have undergone surgical treatment in the past and those who have survived disease-free for more than 5 years meet the inclusion criteria; 5.Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 6.According to RECIST 1.1, at least one measurable lesion; 7.ECOG: 0~1; 8.Expected survival period ≥ 12 weeks; 9.Major organ function has to meet the following certeria:
- Blood routine examination:
- Biochemical examination:
Key exclusion criteria (12 listed)
- Previous history of esophageal cancer surgery；
- Higher risk of esophageal perforation or fistula；
- Received systemic immunosuppressive therapy within 14 days prior to the first study medication；
- Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function;
- The patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, enteritis, systemic lupus erythematosus, rheumatoid arthritis; patients with vitiligo, Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adebrelimab+TP/FP+ radiation therapyInduction stage： Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles; Treatment stage: TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f); Consolidation stage: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs. | Drug | PET-CT responders |
| Adebrelimab+FP/TP+ radiation therapyInduction stage： Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles; Treatment stage: (switch to a different chemotherapy drug which not used during the earlier induction phase) FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f); Consolidation stage: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs. | Drug | PET-CT non-responders |
Primary outcome
Progression free survival (PFS)
Time frame: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
4 secondary outcomes
1. Objective response rate (ORR)
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 monthss
2. Duration of Overall Response（DoR）
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
3. Overall survival (OS)
Time frame: the first day of treatment to death or last survival confirm date,up to 24 months
4. Adverse events
Time frame: up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
Related trials for Esophageal Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Adebrelimab+TP/FP+ radiation therapy and Adebrelimab+FP/TP+ radiation therapy in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: evaluated in 24 months since the treatment began). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.