Locally Advanced, ResectablePhase 2NCT07374003
Ipromlimab and Tuvonralimab Combined With Albumin-Bound Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and Nedaplatin in people with Locally Advanced, Resectable, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a Phase II, single-arm clinical study designed to evaluate the efficacy and safety of Ipromlimab combined with Tuvonralimab, plus Albumin-Bound Paclitaxel and Nedaplatin, as neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced, Resectable
- What is being tested?
- lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and Nedaplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2025to 20 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No prior treatment for the condition.
- Diagnosis of squamous cell carcinoma confirmed by endoscopic biopsy, with agreement to provide a pre-treatment tissue sample.
- Patients must have thoracic esophageal cancer only. The primary site is determined by the center of the mass:
- Upper thoracic esophagus: From the thoracic inlet to the lower border of the aortic arch, corresponding to 20-25 cm from the incisors by endoscopy.
- Middle thoracic esophagus: From the lower border of the aortic arch to the level of the inferior pulmonary veins, corresponding to 25-30 cm from the incisors by endoscopy.
- Lower thoracic esophagus: From the level of the inferior pulmonary veins to the stomach, including the gastroesophageal junction, corresponding to 30-40 cm from the incisors by endoscopy.
Show all 15Show fewer
- Deemed to have potentially resectable disease, with clinical stage III (cT3N1M0 to cT1-3N2M0) according to the UICC/AJCC TNM Staging System, 8th Edition.
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function, meeting the following criteria (without transfusion or hematopoietic growth factor support within 14 days prior to the first dose):
- Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥9.0 g/dL.
- Biochemistry: Total bilirubin <1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × ULN; Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 mL/min.
- Coagulation: International normalized ratio (INR) ≤1.5; Activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Male and female participants of childbearing potential must agree to use medically approved contraceptive methods during the study period and for 6 months after the last dose of the study drug(s).
- The subject is capable of understanding, able to comply with study and follow-up procedures, and voluntarily signs a written informed consent form.
Who cannot join
- Disease assessed as unresectable based on imaging such as contrast-enhanced CT of the chest/abdomen, neck lymph node ultrasound, whole-body PET-CT scan (optional), or endobronchial ultrasound (EBUS) (optional). This includes: the presence of bulky lymph nodes (≥7 suspicious lymph nodes), multi-station lymph node involvement (≥2 stations of suspicious lymph nodes), or distant metastasis.
- History of other malignancies (except for cervical carcinoma in situ or cured, localized basal cell carcinoma of the skin).
- History of autoimmune diseases.
- Recent or current use of corticosteroids or immunosuppressants.
- History of severe hypersensitivity to antibody-based drugs.
- History of chronic or recurrent autoimmune diseases.
Show all 16Show fewer
- History of interstitial lung disease, pulmonary fibrosis, diverticulitis, or systemic ulcerative gastritis.
- Documented history of congestive heart failure, angina pectoris poorly controlled by medication; ECG-confirmed transmural myocardial infarction; uncontrolled hypertension; clinically significant valvular disease; high-risk or uncontrolled arrhythmias.
- Severe systemic concurrent diseases, such as active infection or poorly controlled diabetic complications; coagulation disorders; bleeding tendency; or insufficient thrombolytic/anticoagulant therapy.
- Female participants with a positive serum pregnancy test or who are breastfeeding, or individuals of childbearing potential unwilling to use contraception during the study period.
- Active infection with HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or positive HIV serology; or positive HBV DNA/HCV RNA.
- Allergy to any of the drugs used in this study.
- History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation).
- History of peripheral nervous system disease, significant psychiatric disorder, or central nervous system disease.
- Concurrent use of other anti-tumor drugs.
- Current participation in, or prior participation in, another clinical trial that could potentially impact the results of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Single-Arm Clinical Study of Ipromlimab and Tuvonralimab Combined With Albumin-Bound Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
This is a Phase II, single-arm clinical study designed to evaluate the efficacy and safety of Ipromlimab combined with Tuvonralimab, plus Albumin-Bound Paclitaxel and Nedaplatin, as neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.
Read the detailed description
Eligible patients will receive 2-4 cycles of the combined neoadjuvant therapy (administered every 3 weeks), with response assessed after 2 cycles to determine whether to continue to 4 cycles or proceed to radical esophagectomy. Postoperative management will be tailored based on pathological results: observation for patients achieving pathological complete response (pCR) with R0 resection, adjuvant therapy for non-pCR with R0 resection, and treatment per multidisciplinary team (MDT) decision for non-R0 resection. The primary objective is to assess the pathological complete response (pCR) rate, and secondary objectives include evaluating objective response rate (ORR), disease control rate (DCR), major pathological response (MPR) rate, event-free survival (EFS), disease-free survival (DFS), 3-year disease-free survival rate, overall survival (OS), and safety profile. Exploratory objectives involve identifying predictive biomarkers for neoadjuvant immunotherapy response through multi-omics analysis of biological samples. This study aims to provide evidence for optimizing neoadjuvant treatment strategies in locally advanced resectable esophageal squamous cell carcinoma.
- Conditions
- Locally Advanced, Resectable
- Being tested
- lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and Nedaplatin
- Keywords
- Esophageal Squamous Cell Carcinoma, Neoadjuvant 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.
lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and NedaplatinDrug
- Ipromlimab and Tuvonralimab Dosage: 5 mg/kg, intravenous drip, Day 1, every 3 weeks
- Albumin-Bound Paclitaxel Dosage: 260 mg/m², intravenous drip, Day 1, every 3 weeks
- Nedaplatin Dosage: 75 mg/m², intravenous drip, Day 1, every 3 weeks
Treatment Scheme:
- Neoadjuvant Therapy (2-4 cycles): Patients receive study drugs Q3W. Response is assessed after 2 cycles to decide on continuing to 4 cycles or proceeding to surgery.
- Surgery: Radical esophagectomy is performed within 4-6 weeks post-neoadjuvant therapy.
- Postoperative Management: pCR with R0 resection: Observation. Non-pCR with R0 resection: Adjuvant therapy. Non-R0 resection: Treatment per MDT decision
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1. Ipromlimab and Tuvonralimab Dosage: 5 mg/kg, intravenous drip, Day 1, every 3 weeks
2. Albumin-Bound Paclitaxel Dosage: 260 mg/m², intravenous drip, Day 1, every 3 weeks
3. Nedaplatin Dosage: 75 mg/m², intravenous drip, Day 1, every 3 weeks
Treatment Scheme:
1. Neoadjuvant Therapy (2-4 cycles): Patients receive study drugs Q3W. Response is assessed after 2 cycles to decide on continuing to 4 cycles or proceeding to surgery.
2. Surgery: Radical esophagectomy is performed within 4-6 weeks post-neoadjuvant therapy.
3. Postoperative Management:
pCR with R0 resection: Observation. Non-pCR with R0 resection: Adjuvant therapy. Non-R0 resection: Treatment per MDT decision. Receives: Drug: lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR
Measured: Pathologic Complete Response(pCR) Rate Defined as the proportion of participants with no residual viable tumor cells in the resected surgical specimen. ITime Frame: assessed up to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start17 Dec 2025
- Primary completion20 Jun 2029 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced, ResectableStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374003
- Sponsor's protocol ID
- SL-B2025-677-02
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (lCF)
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Arm Clinical Study of Ipromlimab and Tuvonralimab Combined With Albumin-Bound Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07374003
- Acronym / sponsor ID
- SL-B2025-677-02
- Conditions
- Locally Advanced, Resectable
- Keywords
- Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 20 Jun 2029 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 28 Jan 2026 (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 is a Phase II, single-arm clinical study designed to evaluate the efficacy and safety of Ipromlimab combined with Tuvonralimab, plus Albumin-Bound Paclitaxel and Nedaplatin, as neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.
Detailed description
Eligible patients will receive 2-4 cycles of the combined neoadjuvant therapy (administered every 3 weeks), with response assessed after 2 cycles to determine whether to continue to 4 cycles or proceed to radical esophagectomy. Postoperative management will be tailored based on pathological results: observation for patients achieving pathological complete response (pCR) with R0 resection, adjuvant therapy for non-pCR with R0 resection, and treatment per multidisciplinary team (MDT) decision for non-R0 resection. The primary objective is to assess the pathological complete response (pCR) rate, and secondary objectives include evaluating objective response rate (ORR), disease control rate (DCR), major pathological response (MPR) rate, event-free survival (EFS), disease-free survival (DFS), 3-year disease-free survival rate, overall survival (OS), and safety profile. Exploratory objectives involve identifying predictive biomarkers for neoadjuvant immunotherapy response through multi-omics analysis of biological samples. This study aims to provide evidence for optimizing neoadjuvant treatment strategies in locally advanced resectable esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and Nedaplatin1. Ipromlimab and Tuvonralimab Dosage: 5 mg/kg, intravenous drip, Day 1, every 3 weeks 2. Albumin-Bound Paclitaxel Dosage: 260 mg/m², intravenous drip, Day 1, every 3 weeks 3. Nedaplatin Dosage: 75 mg/m², intravenous drip, Day 1, every 3 weeks Treatment Scheme: 1. Neoadjuvant Therapy (2-4 cycles): Patients receive study drugs Q3W. Response is assessed after 2 cycles to decide on continuing to 4 cycles or proceeding to surgery. 2. Surgery: Radical esophagectomy is performed within 4-6 weeks post-neoadjuvant therapy. 3. Postoperative Management: pCR with R0 resection: Observation. Non-pCR with R0 resection: Adjuvant therapy. Non-R0 resection: Treatment per MDT decision. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- No prior treatment for the condition.
- Diagnosis of squamous cell carcinoma confirmed by endoscopic biopsy, with agreement to provide a pre-treatment tissue sample.
- Patients must have thoracic esophageal cancer only. The primary site is determined by the center of the mass:
- Deemed to have potentially resectable disease, with clinical stage III (cT3N1M0 to cT1-3N2M0) according to the UICC/AJCC TNM Staging System, 8th Edition.
- Age ≥18 years and ≤75 years.
Key exclusion criteria (16 listed)
- Disease assessed as unresectable based on imaging such as contrast-enhanced CT of the chest/abdomen, neck lymph node ultrasound, whole-body PET-CT scan (optional), or endobronchial ultrasound (EBUS) (optional). This includes: the presence of bulky lymph nodes (≥7 suspicious lymph nodes), multi-station lymph node involvement (≥2 stations of suspicious lymph nodes), or distant metastasis.
- History of other malignancies (except for cervical carcinoma in situ or cured, localized basal cell carcinoma of the skin).
- History of autoimmune diseases.
- Recent or current use of corticosteroids or immunosuppressants.
- History of severe hypersensitivity to antibody-based drugs.
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 |
|---|---|---|
| lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and Nedaplatin1. Ipromlimab and Tuvonralimab Dosage: 5 mg/kg, intravenous drip, Day 1, every 3 weeks 2. Albumin-Bound Paclitaxel Dosage: 260 mg/m², intravenous drip, Day 1, every 3 weeks 3. Nedaplatin Dosage: 75 mg/m², intravenous drip, Day 1, every 3 weeks Treatment Scheme: 1. Neoadjuvant Therapy (2-4 cycles): Patients receive study drugs Q3W. Response is assessed after 2 cycles to decide on continuing to 4 cycles or proceeding to surgery. 2. Surgery: Radical esophagectomy is performed within 4-6 weeks post-neoadjuvant therapy. 3. Postoperative Management: pCR with R0 resection: Observation. Non-pCR with R0 resection: Adjuvant therapy. Non-R0 resection: Treatment per MDT decision | Drug | Experimental group |
Primary outcome
PCR
Time frame: Pathologic Complete Response(pCR) Rate Defined as the proportion of participants with no residual viable tumor cells in the resected surgical specimen. ITime Frame: assessed up to 30 days post-surgery
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 28 Jan 2026.
- China Clinical Research RegistrationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (lCF)
Related trials for Locally Advanced, Resectable
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
RecruitingPhase 2
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
Gastroesophageal Adenocarcinoma
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.
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 lpromlimab and Tuvonralimab lpromlimab and Tuvonralimab Combined with Albumin-Bound Paclitaxel and Nedaplatin in people with Locally Advanced, Resectable, run by Sun Yat-sen University 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 15 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 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?
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?
PCR (time frame: Pathologic Complete Response(pCR) Rate Defined as the proportion of participants with no residual viable tumor cells in the resected surgical specimen. ITime Frame: assessed up to 30 days 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 28 Jan 2026.