Esophageal Squamous Cell CarcinomaPhase 2RICENCT06510660
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
A Phase 2 study testing adebrelimab in people with Esophageal Squamous Cell Carcinoma and Immunotherapy, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Immunotherapy, Biomarkers
- What is being tested?
- adebrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years, male or female;
- Have not received systemic or localized treatment in the past;
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (AJCC 8th edition clinical stage II-IVA). IVB stage thoracic esophageal cancer with supraclavicular lymph node metastasis only. No surgical resection or refusal of surgical resection;
- ECOG score of 0-1;
- Life expectancy ≥ 3 months;
- Adequate organ function;
- Fertile men and women must agree to use contraception during the study period and for six months after the last drug used in the study；
- Subjects will voluntarily enroll in the study, sign an informed consent form, be compliant, and cooperate with follow-up visits.
Who cannot join
- Subjects with low body weight (BMI <18.5kg/m2) or ≥10% weight loss in the 2 months prior to screening;
- Esophageal lesions with significant invasion of neighboring organs (e.g., aorta, trachea), or deep and large ulcers with a high risk of bleeding or fistula formation, or previous esophageal perforation or fistula within 6 months prior to screening;
- Prior treatment with immunotherapy;
- Treatment with any other clinical investigational drug or participation in another interventional clinical study within 4 weeks prior to first use of study drug;
- Planning to receive or have received a prophylactic or live attenuated vaccine within 4 weeks prior to the first dose of study drug;
- Receiving corticosteroid hormone therapy within 2 weeks prior to first use of study drug;
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- Subjects who have received a previous tissue/organ transplant or allogeneic hematopoietic stem cell transplant;
- Active, known or suspected autoimmune disease;
- Uncontrolled cardiac clinical symptoms or disease;
- Active or uncontrolled serious infection (≥ CTCAE grade 2 infection);
- Subjects with active tuberculosis or a history of active tuberculosis infection within 12 months prior to screening, with or without treatment;
- History of interstitial lung disease (except radiation pneumonitis not treated with hormonal therapy), or history of non-infectious pneumonia;
- Active hepatitis B virus or hepatitis C virus infection. Positive HIV test or known acquired immunodeficiency syndrome (AIDS);
- Prior history of other malignancies within 5 years (except non-melanoma skin cancer, limited prostate cancer, or any early stage tumor treated by radical resection);
- Known hypersensitivity to any of the investigational drugs or excipients;
- The presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the results of the study, and subjects who, in the opinion of the investigator, are unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Yong Yang, Doctor, 18813019084, dr_yangyong1983@163.com
About this study
Official title: Adebrelimab With or Without Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Phase 2 Trial
To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma
Read the detailed description
This is a prospective, two-cohort, multicenter clinical study. Subjects received different treatments based on their CPS scores. During induction therapy, subjects in cohort 1 (CPS score ≥10) received adebrelimab, while cohort 2 (CPS score < 10) were administered adebrelizumab + carboplatin/cisplatin + paclitaxel/nab-paclitaxel. Both groups received carboplatin/cisplatin + paclitaxel/nab-paclitaxel combined radiotherapy during concurrent chemoradiotherapy. The primary endpoint was cCR rate.
- Being tested
- adebrelimab
- 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.
adebrelimabDrug
The study was divided into two cohorts based on CPS score, with those with CPS scores ≥10 receiving induction therapy with adebrelimab alone and those with CPS scores <10 receiving induction therapy with adebrelimab in combination with chemotherapy. At the end of the induction period, concurrent radiotherapy treatment was administered
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab+Sequential Concurrent Chemoradiotherapy | Experimental | Participants with CPS score ≥10 were enrolled.
Induction therapy: adebrelimab 1200mg iv d1 q3w x 2 cycles for 6 weeks.
Concurrent chemoradiotherapy: carboplatin AUC=2 / cisplatin 25mg/m2 d1 qw + paclitaxel 50mg/m2 / nab-paclitaxel 60mg/m2 d1 qw for a total of 5 weeks; radiotherapy:50Gy/25f, completed in 5 weeks. Receives: Drug: adebrelimab |
| Adebrelimab+Chemotherapy+Sequential Concurrent Chemoradiotherapy | Experimental | Participants with CPS score <10 were enrolled.
Induction therapy: adebrelimab 1200mg iv d1 q3w + carboplatin AUC=6 / cisplatin 75mg/m2 d1 q3w + paclitaxel 175mg/m2 / nab-paclitaxel 260mg/m2 d1 q3w × 2 cycles for 6 weeks.
Concurrent chemoradiotherapy: carboplatin AUC=2 / cisplatin 25mg/m2 d1 qw + paclitaxel 50mg/m2 / nab-paclitaxel 60mg/m2 d1 qw for a total of 5 weeks; radiotherapy:50Gy/25f, completed in 5 weeks. Receives: Drug: adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
cCR
Clinical complete response rates.
Measured: Up to 6 months.
Secondary outcomes (7)
OS
Overall survival.
Measured: From date of enrollment until the date of death from any cause, assessed up to 5 years.
PFS
Progression free survival.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
ORR
Objective response rate.
Measured: Up to 6 months.
DoR
During of response.
Measured: Up to 3 years.
DCR
Disease control rate.
Measured: Up to 6 months.
Completion rate of concurrent radiotherapy
Calculate the percentage of patients who have completed concurrent radiochemotherapy.
Measured: Up to 6 months.
AE
Adverse event,
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start11 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Principal investigator, Yong Yang, Fujian Medical University Union Hospital
- Investigators
- Yong Yang, Doctor, Principal investigator, Fujian Medical University Union HospitalLei Zhao, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510660
- Sponsor's protocol ID
- RICE
- Acronym
- RICE
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adebrelimab With or Without Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT06510660
- Acronym / sponsor ID
- RICE / RICE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Jul 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.
To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma
Detailed description
This is a prospective, two-cohort, multicenter clinical study. Subjects received different treatments based on their CPS scores. During induction therapy, subjects in cohort 1 (CPS score ≥10) received adebrelimab, while cohort 2 (CPS score < 10) were administered adebrelizumab + carboplatin/cisplatin + paclitaxel/nab-paclitaxel. Both groups received carboplatin/cisplatin + paclitaxel/nab-paclitaxel combined radiotherapy during concurrent chemoradiotherapy. The primary endpoint was cCR rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab+Sequential Concurrent Chemoradiotherapy | Experimental | Drug: adebrelimabParticipants with CPS score ≥10 were enrolled. Induction therapy: adebrelimab 1200mg iv d1 q3w x 2 cycles for 6 weeks. Concurrent chemoradiotherapy: carboplatin AUC=2 / cisplatin 25mg/m2 d1 qw + paclitaxel 50mg/m2 / nab-paclitaxel 60mg/m2 d1 qw for a total of 5 weeks; radiotherapy:50Gy/25f, completed in 5 weeks. |
| Adebrelimab+Chemotherapy+Sequential Concurrent Chemoradiotherapy | Experimental | Drug: adebrelimabParticipants with CPS score <10 were enrolled. Induction therapy: adebrelimab 1200mg iv d1 q3w + carboplatin AUC=6 / cisplatin 75mg/m2 d1 q3w + paclitaxel 175mg/m2 / nab-paclitaxel 260mg/m2 d1 q3w × 2 cycles for 6 weeks. Concurrent chemoradiotherapy: carboplatin AUC=2 / cisplatin 25mg/m2 d1 qw + paclitaxel 50mg/m2 / nab-paclitaxel 60mg/m2 d1 qw for a total of 5 weeks; radiotherapy:50Gy/25f, completed in 5 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-70 years, male or female;
- Have not received systemic or localized treatment in the past;
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (AJCC 8th edition clinical stage II-IVA). IVB stage thoracic esophageal cancer with supraclavicular lymph node metastasis only. No surgical resection or refusal of surgical resection;
- ECOG score of 0-1;
- Life expectancy ≥ 3 months;
Key exclusion criteria (16 listed)
- Subjects with low body weight (BMI <18.5kg/m2) or ≥10% weight loss in the 2 months prior to screening;
- Esophageal lesions with significant invasion of neighboring organs (e.g., aorta, trachea), or deep and large ulcers with a high risk of bleeding or fistula formation, or previous esophageal perforation or fistula within 6 months prior to screening;
- Prior treatment with immunotherapy;
- Treatment with any other clinical investigational drug or participation in another interventional clinical study within 4 weeks prior to first use of study drug;
- Planning to receive or have received a prophylactic or live attenuated vaccine within 4 weeks prior to the first dose of study drug;
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 |
|---|---|---|
| adebrelimabThe study was divided into two cohorts based on CPS score, with those with CPS scores ≥10 receiving induction therapy with adebrelimab alone and those with CPS scores <10 receiving induction therapy with adebrelimab in combination with chemotherapy. At the end of the induction period, concurrent radiotherapy treatment was administered | Drug | Adebrelimab+Chemotherapy+Sequential Concurrent Chemoradiotherapy, Adebrelimab+Sequential Concurrent Chemoradiotherapy |
Primary outcome
cCR
Time frame: Up to 6 months.
Clinical complete response rates.
7 secondary outcomes
OS
Time frame: From date of enrollment until the date of death from any cause, assessed up to 5 years.
PFS
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
ORR
Time frame: Up to 6 months.
DoR
Time frame: Up to 3 years.
DCR
Time frame: Up to 6 months.
Completion rate of concurrent radiotherapy
Time frame: Up to 6 months.
AE
Time frame: Up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Yong Yang, Doctor principal investigator
Fujian Medical University Union Hospital
Lei Zhao principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adebrelimab in people with Esophageal Squamous Cell Carcinoma and Immunotherapy, run by Fujian Medical University Union Hospital at 1 site in China.
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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Yang, Doctor (18813019084, dr_yangyong1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cCR (time frame: Up to 6 months.). 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 Oct 2026.