ESCCPhase 2NCT07493993
Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel in people with ESCC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Major objectives to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESCC
- What is being tested?
- lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2030
- 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
- Voluntarily understand and sign the informed consent form for this study.
- Age ≥ 18 years, male or female.
- Histologically or cytologically confirmed thoracic ESCC (Stage T1-2N1-2M0 or T3N0-2M0, according to the AJCC 8th edition).
- ECOG performance status of 0-2.
- No prior treatment for esophageal squamous cell carcinoma.
- Life expectancy ≥ 3 months.
- Adequate function of major organs within 7 days before the first treatment (use of any blood components or cell growth factors within 14 days before enrollment is not permitted):Hemoglobin ≥ 90 g/L; White blood cell count ≥ 3.5 × 10^9/L; Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 80 × 10^9/L; AST and ALT ≤ 2.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance (CCr) ≥ 50 mL/min); Left ventricular ejection fraction (LVEF) ≥ 50%.
- Fertile patients must agree to use reliable contraceptive methods with their partner during the trial and for at least 180 days after the last dose.
Who cannot join
- Inability to comply with the study protocol or study procedures.
- Presence of supraclavicular lymph node metastasis.
- Obvious tumor invasion of organs adjacent to the esophageal lesion.
- Evidence of esophagomediastinal or tracheoesophageal fistula found on imaging within 4 weeks before enrollment.
- Allergy or known hypersensitivity to the study drugs or their excipients.
- Anticipated need for systemic corticosteroids or other immunosuppressive therapy during the study treatment period.
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- Active autoimmune disease requiring systemic treatment, or a history of autoimmune disease.
- Positive HIV test; positive hepatitis B surface antigen with HBV-DNA > upper limit of normal; active hepatitis C virus (HCV) infection.
- History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months before the first study drug administration; known severe varices on endoscopy within 3 months before the first study drug administration.
- Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia that might interfere with the assessment and management of immune-related pulmonary toxicity.
- Evidence of a significant bleeding tendency or other major coagulation disorders.
- Severe cardiovascular or cerebrovascular disease.
- Other malignancies within 5 years before enrollment, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- History of allogeneic bone marrow transplantation or organ transplantation.
- Patients considered by the investigator to be 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.
Chang Liu contact
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
Zhansheng Jiang, 13512035574, 18526812877@163.com
About this study
Major objectives to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.
Read the detailed description
This clinical study aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
- Conditions
- ESCC
- Being tested
- lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel
- Keywords
- Iparomlimab and Tuvonralimab Injection, Nab-Paclitaxel, neoadjuvant therapy, ESCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lparomlimab and Tuvonralimab Injection in Combination with Nab-PaclitaxelDrug
Iparomlimab and Tuvonralimab Injection: 5 mg/kg, q3w; Nab-Paclitaxel: 125 mg/m² on d1 and d8, q3w; Neoadjuvant therapy is administered for 4 cycles. The appropriate surgical timing will be determined by the physician based on the patient's condition, and surgery is scheduled for 4-6 weeks after the completion of neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel | Experimental | lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel Receives: Drug: lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate (pCR)
refers to the absence of viable tumor cells in both the primary tumor bed and the regional lymph nodes in the surgically resected specimens.
Measured: up to 6 month
Secondary outcomes (6)
Major Pathologic Response rate (MPR)
Measured: up to 12 month
R0 Resection rate
Measured: up to 12 month
Event-Free Survival (EFS)
Measured: up to 12 month
Disease-Free Survival (DFS)
Measured: up to 12 month
Overall survival
Os was defined as the time from the first dose of study drug to death due to anycause.
Measured: up to 36 month
Adverse Events
An AE was defined as any untoward medical occurrence in a pharmaceutical productwhich does not necessarily have to have a causal relationship with this treatment.
Measured: up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493993
- Sponsor's protocol ID
- E20260292
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07493993
- Acronym / sponsor ID
- E20260292
- Conditions
- ESCC
- Keywords
- Iparomlimab and Tuvonralimab Injection, Nab-Paclitaxel, neoadjuvant therapy, ESCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Mar 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.
Major objectives to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.
Detailed description
This clinical study aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel | Experimental | Drug: lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxellparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily understand and sign the informed consent form for this study.
- Age ≥ 18 years, male or female.
- Histologically or cytologically confirmed thoracic ESCC (Stage T1-2N1-2M0 or T3N0-2M0, according to the AJCC 8th edition).
- ECOG performance status of 0-2.
- No prior treatment for esophageal squamous cell carcinoma.
Key exclusion criteria (15 listed)
- Inability to comply with the study protocol or study procedures.
- Presence of supraclavicular lymph node metastasis.
- Obvious tumor invasion of organs adjacent to the esophageal lesion.
- Evidence of esophagomediastinal or tracheoesophageal fistula found on imaging within 4 weeks before enrollment.
- Allergy or known hypersensitivity to the study drugs or their excipients.
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 |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with Nab-PaclitaxelIparomlimab and Tuvonralimab Injection: 5 mg/kg, q3w; Nab-Paclitaxel: 125 mg/m² on d1 and d8, q3w; Neoadjuvant therapy is administered for 4 cycles. The appropriate surgical timing will be determined by the physician based on the patient's condition, and surgery is scheduled for 4-6 weeks after the completion of neoadjuvant therapy. | Drug | lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel |
Primary outcome
Pathologic complete response rate (pCR)
Time frame: up to 6 month
refers to the absence of viable tumor cells in both the primary tumor bed and the regional lymph nodes in the surgically resected specimens.
6 secondary outcomes
Major Pathologic Response rate (MPR)
Time frame: up to 12 month
R0 Resection rate
Time frame: up to 12 month
Event-Free Survival (EFS)
Time frame: up to 12 month
Disease-Free Survival (DFS)
Time frame: up to 12 month
Overall survival
Time frame: up to 36 month
Adverse Events
Time frame: up to 36 month
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 27 Mar 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.
Chang Liu contact
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 lparomlimab and Tuvonralimab Injection in Combination with Nab-Paclitaxel in people with ESCC, run by Tianjin Medical University Cancer Institute and 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 15 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 27 Mar 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 Zhansheng Jiang, Doctor (13512035574, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate (pCR) (time frame: up to 6 month). 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 27 Mar 2026.