Esophageal Squamous CarcinomaPhase 2NCT07490002
Neoadjuvant Therapy With Iparomlimab and Tuvonralimab, Lenvatinib and Chemotherapy in Resectable ESCC
A Phase 2 study testing Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel in people with Esophageal Squamous Carcinoma, run by Changhai Hospital.
Trial summary
This is a single-arm, exploratory clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Carcinoma
- What is being tested?
- Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 6 Apr 2026to 30 Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: no restriction; Age: 18-75 years.
- Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.
- Clinical stage II-IVa (T2-4aN+M0) according to the AJCC 8th edition, and assessed as resectable by a multidisciplinary team (MDT).
- Complete imaging work-up shows no evidence of distant metastasis:
- Neck ultrasound and contrast-enhanced chest/abdominal CT.
- Ultrasound-guided lymph node biopsy or PET/CT if clinical suspicion or neck ultrasound suggests cervical lymph node metastasis.
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- Abdominal non-contrast and contrast-enhanced MRI or PET/CT to confirm diagnosis if CT suggests liver metastasis.
- Bone scan if necessary in case of systemic bone pain symptoms.
- Endoscopic ultrasound for accurate staging.
- No prior antitumor therapy received (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine).
- ECOG Performance Status score: 0-1.
- Adequate organ function, meeting the following laboratory criteria (no blood transfusion, granulocyte colony-stimulating factor [G-CSF], or corrective medication within 14 days prior to treatment):
- 1）Hemoglobin (Hb) ≥90 g/L. 2）Absolute neutrophil count (ANC) ≥1.5×10⁹/L. 3）Platelet count (PLT) ≥100×10⁹/L. 4）Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN). 5）Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN. 6）Serum creatinine clearance (CrCl) ≥50 mL/min (calculated by Cockcroft-Gault formula). 7）Coagulation: International normalized ratio (INR) ≤1.5 × ULN, activated partial thromboplastin time (APTT) ≤1.5 × ULN. 8）Proteinuria < 2+ (if ≥ 2+, a 24-hour urine protein quantification must be performed; patients are eligible if the result is ≤1 g). 9）Left ventricular ejection fraction (LVEF) ≥50%.
- No surgical contraindications.
- The subject agrees to use effective contraception from the signing of the informed consent form until 180 days after the last dose. Female subjects of childbearing potential must not be pregnant or breastfeeding.
- Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
Who cannot join
- Known history of hypersensitivity to macromolecular protein preparations. Contraindications or allergies to any component of epaplimut-pembrolizumab.
- Other anti-tumor therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, chemoembolization, anti-tumor traditional Chinese herbal medicine).
- Radiographic diagnosis indicating distant metastasis of the tumor.
- History of allogeneic tissue/solid organ transplantation.
- Within 2 weeks prior to the first dose, presence of a condition requiring systemic corticosteroid (>10 mg daily prednisone or equivalent) or other immunosuppressive medication (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.). Topical, nasal spray, and inhaled corticosteroids are permitted. Prophylactic use of systemic corticosteroids for contrast agent allergy is allowed.
- Active or potentially recurrent autoimmune diseases, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes requiring only stable-dose insulin replacement therapy.
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- Other active malignancies within the past 5 years, except for cured localized cancers (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast) and breast cancer without recurrence for more than 3 years after radical surgery.
- History of interstitial lung disease and/or pneumonitis or pulmonary hypertension.
- Poorly controlled ascites, pericardial effusion, or pleural effusion requiring repeated drainage.
- Poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) and diabetes despite standard treatment, or uncontrolled or symptomatic arrhythmia.
- Thromboembolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or pulmonary embolism.
- Myocardial infarction within the past 12 months, severe/unstable angina, or symptomatic congestive heart failure (NYHA class III or IV).
- Participation in other clinical trials within 60 days prior to or during the treatment period.
- Known active infection with HIV, HBV, or HCV.
- Major surgery (excluding needle biopsy) within 4 weeks prior to the first dose without full recovery.
- Any other condition deemed by the investigator as inappropriate for inclusion in this study.
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: A Phase II Clinical Study of Neoadjuvant Therapy With Epacadostat, Lenvatinib, and Chemotherapy in Surgically Resectable Esophageal Cancer
This is a single-arm, exploratory clinical study.
Read the detailed description
This study is a single-arm, single-center, prospective clinical trial. A total of 33 subjects are planned to be enrolled. The study consists of a screening period, a treatment period, and a post-treatment follow-up period. After providing signed informed consent and meeting eligibility criteria, subjects will receive neoadjuvant therapy with epacadostat, tovorafenib, lenvatinib, cisplatin/carboplatin, and nab-paclitaxel. Treatment will be administered in 3-week cycles, with a total of 3 preoperative cycles (lenvatinib will be discontinued in the third cycle).
- Conditions
- Esophageal Squamous Carcinoma
- Being tested
- Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxelDrug
Iparomlimab and Tuvonralimab: 5 mg/kg, Day 1;
Lenvatinib: 8 mg, orally, once daily (QD), Day 1-14; Note: Lenvatinib will be discontinued starting from Cycle 3.
Cisplatin: 75 mg/m², or Carboplatin: AUC 5, intravenously (IV), Day 1;
Nab-paclitaxel: 125 mg/m², Day 1 and Day 8;
The cycle repeats every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab + Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel | Experimental | Iparomlimab and Tuvonralimab: 5 mg/kg, Day 1;
Lenvatinib: 8 mg, orally, once daily (QD), Day 1-14; Note: Lenvatinib will be discontinued starting from Cycle 3.
Cisplatin: 75 mg/m², or Carboplatin: AUC 5, intravenously (IV), Day 1;
Nab-paclitaxel: 125 mg/m², Day 1 and Day 8;
The cycle repeats every 3 weeks. Receives: Drug: Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response, pCR
Measured: Periprocedural
Secondary outcomes (3)
objective response rate (ORR)
Measured: Up to 2 years
Major Pathologic Response（MPR）
In the tumor bed of the surgical resection specimen, necrotic or regressive tumor tissue ≥90 %.
Measured: Periprocedural
Progression-Free Survival (PFS)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start6 Apr 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous CarcinomaStudies of the same condition, open and under way.
- More trials run by Changhai 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490002
- Sponsor's protocol ID
- CHEC2025-497
- Status last verified
- Dec 2025
- First submitted
- 5 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Neoadjuvant Therapy With Epacadostat, Lenvatinib, and Chemotherapy in Surgically Resectable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07490002
- Acronym / sponsor ID
- CHEC2025-497
- Conditions
- Esophageal Squamous Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 6 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 24 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.
This is a single-arm, exploratory clinical study.
Detailed description
This study is a single-arm, single-center, prospective clinical trial. A total of 33 subjects are planned to be enrolled. The study consists of a screening period, a treatment period, and a post-treatment follow-up period. After providing signed informed consent and meeting eligibility criteria, subjects will receive neoadjuvant therapy with epacadostat, tovorafenib, lenvatinib, cisplatin/carboplatin, and nab-paclitaxel. Treatment will be administered in 3-week cycles, with a total of 3 preoperative cycles (lenvatinib will be discontinued in the third cycle).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab + Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel | Experimental | Drug: Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxelIparomlimab and Tuvonralimab: 5 mg/kg, Day 1; Lenvatinib: 8 mg, orally, once daily (QD), Day 1-14; Note: Lenvatinib will be discontinued starting from Cycle 3. Cisplatin: 75 mg/m², or Carboplatin: AUC 5, intravenously (IV), Day 1; Nab-paclitaxel: 125 mg/m², Day 1 and Day 8; The cycle repeats every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Gender: no restriction; Age: 18-75 years.
- Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.
- Clinical stage II-IVa (T2-4aN+M0) according to the AJCC 8th edition, and assessed as resectable by a multidisciplinary team (MDT).
- Complete imaging work-up shows no evidence of distant metastasis:
- No prior antitumor therapy received (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine).
Key exclusion criteria (16 listed)
- Known history of hypersensitivity to macromolecular protein preparations. Contraindications or allergies to any component of epaplimut-pembrolizumab.
- Other anti-tumor therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, chemoembolization, anti-tumor traditional Chinese herbal medicine).
- Radiographic diagnosis indicating distant metastasis of the tumor.
- History of allogeneic tissue/solid organ transplantation.
- Within 2 weeks prior to the first dose, presence of a condition requiring systemic corticosteroid (>10 mg daily prednisone or equivalent) or other immunosuppressive medication (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.). Topical, nasal spray, and inhaled corticosteroids are permitted. Prophylactic use of systemic corticosteroids for contrast agent allergy is allowed.
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 |
|---|---|---|
| Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxelIparomlimab and Tuvonralimab: 5 mg/kg, Day 1; Lenvatinib: 8 mg, orally, once daily (QD), Day 1-14; Note: Lenvatinib will be discontinued starting from Cycle 3. Cisplatin: 75 mg/m², or Carboplatin: AUC 5, intravenously (IV), Day 1; Nab-paclitaxel: 125 mg/m², Day 1 and Day 8; The cycle repeats every 3 weeks. | Drug | Iparomlimab and Tuvonralimab + Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel |
Primary outcome
Pathological Complete Response, pCR
Time frame: Periprocedural
3 secondary outcomes
objective response rate (ORR)
Time frame: Up to 2 years
Major Pathologic Response（MPR）
Time frame: Periprocedural
Progression-Free Survival (PFS)
Time frame: Up to 2 years
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 24 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel in people with Esophageal Squamous Carcinoma, run by Changhai 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 16 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: opening soon, as of the sponsor's last update on 24 Mar 2026. 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 Xianbao Zhan (862131162338, zhanxianbao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response, pCR (time frame: Periprocedural). 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 24 Mar 2026.