Esophageal CancerPhase 2BRICESNCT07283991
QL1706 Plus Chemotherapy for Borderline Resectable Esophageal Cancer
A Phase 2 study testing chemotherapy combined with Aparolitolovureli immunotherapy in people with Esophageal Cancer, run by Ruijin Hospital.
Trial summary
China bears a disproportionately high burden of esophageal cancer, accounting for approximately 50% of newly diagnosed cases worldwide, with an average 5-year survival rate of only 30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- chemotherapy combined with Aparolitolovureli immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 1 Aug 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed esophageal squamous cell carcinoma.
- Clinical stage cT4a, or at least one lymph node suspected of invading adjacent structures, or conglomerated/enlarged lymph nodes, or supraclavicular lymph node metastasis.
- No prior anti-tumor treatment before enrollment.
- Age ≥ 18 years.
- ECOG Performance Status score of 0-1.
- Signed written informed consent.
Who cannot join
- Presence of autoimmune disease.
- Requiring systemic corticosteroid therapy or other immunosuppressive medications.
- Symptomatic interstitial lung disease.
- Known hypersensitivity to the investigational drug(s).
- Pregnant or breastfeeding women.
- Patients of childbearing potential who refuse to use effective contraception.
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- Prior treatment with immune checkpoint inhibitors or any agents targeting T-cell co-stimulatory/co-inhibitory pathways.
- Any condition deemed by the investigator to increase treatment risk or confound study outcome assessment.
- Prior esophageal cancer-related chemotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Single-Arm Study of QL1706 Plus Chemotherapy for Borderline Resectable Esophageal Cancer
China bears a disproportionately high burden of esophageal cancer, accounting for approximately 50% of newly diagnosed cases worldwide, with an average 5-year survival rate of only 30%. Esophageal adenocarcinoma and squamous cell carcinoma (ESCC) are the major pathological subtypes, among which squamous cell carcinoma predominates in Asian populations. More than 90% of esophageal cancer cases in China are ESCC.
Optimal treatment for locally advanced esophageal cancer remains a matter of debate. Findings from Japanese clinical studies such as JCOG1109 have demonstrated that neoadjuvant chemotherapy can significantly improve long-term survival in patients with locally advanced ESCC. Neoadjuvant chemotherapy followed by surgery has therefore become one of the preferred treatment strategies.
Read more
Preclinical evidence suggests synergistic interactions between chemotherapy and immunotherapy, potentially enhancing treatment efficacy. Moreover, clinical trials such as ESCORT-NEO and NCCES01 have validated the safety and effectiveness of immunochemotherapy for locally advanced esophageal cancer. Consequently, chemotherapy combined with immunotherapy has emerged as a promising approach for improving survival outcomes in this patient population.
A Phase II clinical trial involving the investigational drug Aparolitolovureli was conducted in 39 patients with unresectable locally advanced ESCC, evaluating a regimen of radical chemoradiotherapy combined with immunotherapy followed by Aparolitolovureli maintenance. The study reported a median progression-free survival (mPFS) of 13.99 months, with 12-month PFS and OS rates of 62.1% and 86.2%, respectively, demonstrating encouraging efficacy. These results, together with supporting preclinical data, suggest that immunochemotherapy is both feasible and effective in locally advanced esophageal cancer.
Based on this foundation, our research team proposes a single-arm clinical study in patients with borderline resectable locally advanced ESCC. A total of 24 participants will receive 2-4 cycles of inductive immunochemotherapy with Aparolitolovureli plus cisplatin and paclitaxel. Patients deemed resectable after reassessment will undergo radical esophagectomy, followed by Aparolitolovureli maintenance therapy. The study aims to evaluate the efficacy and safety of this treatment strategy and provide scientific evidence and clinical guidance to improve the overall prognosis of patients with ESCC.
- Conditions
- Esophageal Cancer
- Being tested
- chemotherapy combined with Aparolitolovureli immunotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapy combined with Aparolitolovureli immunotherapyDrug
After enrollment, patients will receive first-stage treatment consisting of cisplatin plus nanoparticle albumin-bound paclitaxel chemotherapy combined with Aparolitolovureli immunotherapy for 2 to 4 cycles. If the tumor is assessed as resectable, radical esophagectomy will be performed. If the tumor remains unresectable, definitive concurrent chemoradiotherapy will be administered. Following radical esophagectomy, patients will enter the second stage of treatment with Aparolitolovureli maintenance immunotherapy for up to 1 year (a maximum of 14 cycles during the maintenance phase).
| Study group | Role | What they receive |
|---|---|---|
| Aparolitolovureli plus chemotherapy group | Experimental | Not described Receives: Drug: chemotherapy combined with Aparolitolovureli immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
R0 resection rate confirmed by pathological evaluation.
Measured: at 2 weeks post-surgery
Secondary outcomes (4)
major pathological response rate
short-term efficacy of the treatment regimen (major pathological response rate) .The proportion of patients achieving major pathological response, as assessed by tumor regression grading on postoperative pathological specimens.
Measured: at 2 weeks post-surgery
radiological response rate
short-term efficacy of the treatment regimen（radiological) . The objective response rate (complete response + partial response) assessed according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Measured: at 1 months post-treatment
3-year progression-free survival rate
long-term oncological outcomes (3-year progression-free survival) The proportion of patients alive and free from disease progression within 3 years from the initiation of treatment.
Measured: at 3 years post-treatment
3-year overall survival rate
long-term oncological outcomes (3-year overall survival) . The proportion of patients alive at 3 years from the initiation of treatment, regardless of the cause of death.
Measured: at 3 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Ruijin 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283991
- Sponsor's protocol ID
- RTS-028
- Other IDs
- MR-31-25-068250
- Acronym
- BRICES
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-Arm Study of QL1706 Plus Chemotherapy for Borderline Resectable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07283991
- Acronym / sponsor ID
- BRICES / RTS-028
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 16 Dec 2025 (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.
China bears a disproportionately high burden of esophageal cancer, accounting for approximately 50% of newly diagnosed cases worldwide, with an average 5-year survival rate of only 30%. Esophageal adenocarcinoma and squamous cell carcinoma (ESCC) are the major pathological subtypes, among which squamous cell carcinoma predominates in Asian populations. More than 90% of esophageal cancer cases in China are ESCC.
Optimal treatment for locally advanced esophageal cancer remains a matter of debate. Findings from Japanese clinical studies such as JCOG1109 have demonstrated that neoadjuvant chemotherapy can significantly improve long-term survival in patients with locally advanced ESCC. Neoadjuvant chemotherapy followed by surgery has therefore become one of the preferred treatment strategies.
Preclinical evidence suggests synergistic interactions between chemotherapy and immunotherapy, potentially enhancing treatment efficacy. Moreover, clinical trials such as ESCORT-NEO and NCCES01 have validated the safety and effectiveness of immunochemotherapy for locally advanced esophageal cancer. Consequently, chemotherapy combined with immunotherapy has emerged as a promising approach for improving survival outcomes in this patient population.
A Phase II clinical trial involving the investigational drug Aparolitolovureli was conducted in 39 patients with unresectable locally advanced ESCC, evaluating a regimen of radical chemoradiotherapy combined with immunotherapy followed by Aparolitolovureli maintenance. The study reported a median progression-free survival (mPFS) of 13.99 months, with 12-month PFS and OS rates of 62.1% and 86.2%, respectively, demonstrating encouraging efficacy. These results, together with supporting preclinical data, suggest that immunochemotherapy is both feasible and effective in locally advanced esophageal cancer.
Based on this foundation, our research team proposes a single-arm clinical study in patients with borderline resectable locally advanced ESCC. A total of 24 participants will receive 2-4 cycles of inductive immunochemotherapy with Aparolitolovureli plus cisplatin and paclitaxel. Patients deemed resectable after reassessment will undergo radical esophagectomy, followed by Aparolitolovureli maintenance therapy. The study aims to evaluate the efficacy and safety of this treatment strategy and provide scientific evidence and clinical guidance to improve the overall prognosis of patients with ESCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aparolitolovureli plus chemotherapy group | Experimental | Drug: chemotherapy combined with Aparolitolovureli immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed esophageal squamous cell carcinoma.
- Clinical stage cT4a, or at least one lymph node suspected of invading adjacent structures, or conglomerated/enlarged lymph nodes, or supraclavicular lymph node metastasis.
- No prior anti-tumor treatment before enrollment.
- Age ≥ 18 years.
- ECOG Performance Status score of 0-1.
Key exclusion criteria (9 listed)
- Presence of autoimmune disease.
- Requiring systemic corticosteroid therapy or other immunosuppressive medications.
- Symptomatic interstitial lung disease.
- Known hypersensitivity to the investigational drug(s).
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| chemotherapy combined with Aparolitolovureli immunotherapyAfter enrollment, patients will receive first-stage treatment consisting of cisplatin plus nanoparticle albumin-bound paclitaxel chemotherapy combined with Aparolitolovureli immunotherapy for 2 to 4 cycles. If the tumor is assessed as resectable, radical esophagectomy will be performed. If the tumor remains unresectable, definitive concurrent chemoradiotherapy will be administered. Following radical esophagectomy, patients will enter the second stage of treatment with Aparolitolovureli maintenance immunotherapy for up to 1 year (a maximum of 14 cycles during the maintenance phase). | Drug | Aparolitolovureli plus chemotherapy group |
Primary outcome
R0 resection rate
Time frame: at 2 weeks post-surgery
R0 resection rate confirmed by pathological evaluation.
4 secondary outcomes
major pathological response rate
Time frame: at 2 weeks post-surgery
radiological response rate
Time frame: at 1 months post-treatment
3-year progression-free survival rate
Time frame: at 3 years post-treatment
3-year overall survival rate
Time frame: at 3 years post-treatment
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. Deidentified participant data
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy combined with Aparolitolovureli immunotherapy in people with Esophageal Cancer, run by Ruijin 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 16 Dec 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.
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 Hecheng Li (021-021-64370045, lihecheng2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: at 2 weeks post-surgery). 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 16 Dec 2025.