Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT07290010
The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Iparomlimab and Tuvonralimab combined with chemotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Iparomlimab and Tuvonralimab combined with chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2025to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, gender not limited;
- Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous carcinoma mixed type and other pathological types);
- For patients who have previously received adjuvant/neoadjuvant chemotherapy/chemoradiotherapy, or radical concurrent chemoradiotherapy , the time from the last treatment to disease recurrence is more than 6 months;
- ECOG 0-1;
- According to RECIST v1.1, there is at least one measurable lesion;
- Be capable of providing newly obtained or archived tissue samples for immunohistochemical analysis of PD-L1 expression;
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- The patient's organ functions are normal, with no serious abnormalities in blood, heart, lung, liver or kidney functions, and no immune deficiency diseases.
- The patient has normal coagulation function and no active bleeding or thrombotic diseases.
- Expected survival time ≥12 weeks;
- Male subjects who are female of childbearing age or whose sexual partners are female of childbearing age must take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period.
- Voluntarily sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan
Who cannot join
- Locally advanced esophageal cancer that can be potentially cured through radical surgical resection or radiotherapy;
- Esophageal squamous cell carcinoma that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction;
- There is a risk of perforation after stent implantation in the esophageal or tracheal cavity;
- Has received systemic treatment for advanced or metastatic esophageal squamous cell carcinoma in the past;
- Other malignant tumors diagnosed within 5 years prior to the first administration, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or effectively resected cervical cancer and/or breast cancer in situ;
- Severe infection occurs (CTCAE>grade 2), or active pulmonary inflammation;
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- Previous or current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung function impairment;
- Patients with active tuberculosis infection;
- Participate in another interventional clinical study simultaneously, unless participating in an observational (non-interventional) clinical study or being in the follow-up stage of an interventional study;
- Patients with congenital or acquired immune deficiencies, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit), or patients with co-infection of hepatitis B and hepatitis C;
- There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Having undergone major surgical operations (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first dose of the study treatment or expecting to undergo major surgeries during the study treatment period;
- It is known that there are symptomatic central nervous system metastases and/or cancerous meningitis (except for stable brain metastases that do not require steroid treatment);
- It is known that there is an active autoimmune disease requiring symptomatic treatment or a history of the disease within the past 2 years (patients with vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment in the past 2 years, hypothyroidism who only need thyroid hormone replacement therapy, and type 1 diabetes who only need insulin replacement therapy can be enrolled).
- Female patients who are pregnant or breastfeeding;
- Any serious or uncontrolled systemic disease that researchers believe may increase the risk of participation in patients
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
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Shengmian Li, +8613931185237, shengmianli2013@163.com
About this study
Official title: A Clinical Trial to Explore the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). After screening and meeting the inclusion criteria, the patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events, with a total maximum treatment duration of 24 months.
The main objective of this study is to: 1. evaluate the ORR of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. 2. The secondary endpoints include PFS, DCR, DoR, OS and safety, etc.
- Being tested
- Iparomlimab and Tuvonralimab combined with chemotherapy
- Keywords
- immunotherapy, ESCC, PD-1/CTLA-4, Esophageal Squamous Cell Carcinoma
- 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.
Iparomlimab and Tuvonralimab combined with chemotherapyDrug
Patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events 1. Iparomlimab and Tuvonralimab Injection: 5 mg/kg, d1, Q3W; 2. Albumin-bound paclitaxel:100-150 mg/m², d1, d8, Q3W; 3. Cisplatin: 75 mg/m², d1, Q3W;
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab combined with chemotherapy | Experimental | Patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events
1. Iparomlimab and Tuvonralimab Injection: 5 mg/kg, d1, Q3W;
2. Albumin-bound paclitaxel:100-150 mg/m², d1, d8, Q3W;
3. Cisplatin: 75 mg/m², d1, Q3W; Receives: Drug: Iparomlimab and Tuvonralimab combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate（ORR）
The objective response rate (ORR) evaluated by investigator based on RECIST 1.1
Measured: 18months
Secondary outcomes (5)
Progression-free survival （PFS）
The Progression-free survival (PFS) evaluated by investigator based on RECIST 1.1
Measured: 24months
Disease control rate (DCR)
Disease control rate (DCR) evaluated by investigator based on RECIST 1.1
Measured: 18months
Duration of response (DoR)
Duration of response (DoR) evaluated by investigator based on RECIST 1.1
Measured: 24months
Overall survival（OS）
Overall survival（OS）
Measured: 30months
Adverse events（AEs）
The incidence and severity of adverse events (AEs) : The incidence and severity of adverse events (AE) and serious adverse events (SAE) were determined based on the NCI-CTCAE v5.0 standard. Abnormal vital signs and laboratory tests, etc
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start26 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 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 Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290010
- Sponsor's protocol ID
- 2025KY012
- Status last verified
- Oct 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Explore the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07290010
- Acronym / sponsor ID
- 2025KY012
- Keywords
- immunotherapy, ESCC, PD-1/CTLA-4, Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 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.
This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). After screening and meeting the inclusion criteria, the patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events, with a total maximum treatment duration of 24 months.
The main objective of this study is to: 1. evaluate the ORR of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. 2. The secondary endpoints include PFS, DCR, DoR, OS and safety, etc.
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 combined with chemotherapy | Experimental | Drug: Iparomlimab and Tuvonralimab combined with chemotherapyPatients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events 1. Iparomlimab and Tuvonralimab Injection: 5 mg/kg, d1, Q3W; 2. Albumin-bound paclitaxel:100-150 mg/m², d1, d8, Q3W; 3. Cisplatin: 75 mg/m², d1, Q3W; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years old, gender not limited;
- Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous carcinoma mixed type and other pathological types);
- For patients who have previously received adjuvant/neoadjuvant chemotherapy/chemoradiotherapy, or radical concurrent chemoradiotherapy , the time from the last treatment to disease recurrence is more than 6 months;
- ECOG 0-1;
- According to RECIST v1.1, there is at least one measurable lesion;
Key exclusion criteria (16 listed)
- Locally advanced esophageal cancer that can be potentially cured through radical surgical resection or radiotherapy;
- Esophageal squamous cell carcinoma that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction;
- There is a risk of perforation after stent implantation in the esophageal or tracheal cavity;
- Has received systemic treatment for advanced or metastatic esophageal squamous cell carcinoma in the past;
- Other malignant tumors diagnosed within 5 years prior to the first administration, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or effectively resected cervical cancer and/or breast cancer in situ;
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 combined with chemotherapyPatients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events 1. Iparomlimab and Tuvonralimab Injection: 5 mg/kg, d1, Q3W; 2. Albumin-bound paclitaxel:100-150 mg/m², d1, d8, Q3W; 3. Cisplatin: 75 mg/m², d1, Q3W; | Drug | Iparomlimab and Tuvonralimab combined with chemotherapy |
Primary outcome
Objective response rate（ORR）
Time frame: 18months
The objective response rate (ORR) evaluated by investigator based on RECIST 1.1
5 secondary outcomes
Progression-free survival （PFS）
Time frame: 24months
Disease control rate (DCR)
Time frame: 18months
Duration of response (DoR)
Time frame: 24months
Overall survival（OS）
Time frame: 30months
Adverse events（AEs）
Time frame: 24months
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 17 Dec 2025.
- 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.
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 Iparomlimab and Tuvonralimab combined with chemotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Hebei Medical University Fourth 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 11 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 17 Dec 2025. 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 Shengmian Li (+8613931185237, shengmianli2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate（ORR） (time frame: 18months). 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 17 Dec 2025.