The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma

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

The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma (NCT07290010) is a Phase 2 interventional studying Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Hebei Medical University Fourth Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Squamous Cell Carcinoma (ESCC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 25 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years old, gender not limited; 2. Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous carcinoma mixed type and other pathological types); 3. 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; 4. ECOG 0-1; 5. According to RECIST v1.1, there is at least one measurable lesion; 6. Be capable of providing newly obtained or archived tissue samples for immunohistochemical analysis of PD-L1 expression; 7. The patient's organ functions are normal, with no serious abnormalities in blood, heart, lung, liver or kidney functions, and no immune deficiency diseases. 8. The patient has normal coagulation function and no active bleeding or thrombotic diseases. 9. Expected survival time ≥12 weeks; 10. 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. 11. Voluntarily sign a written willing to sign a consent form form and be able to comply with the visitation and related procedures stipulated in the plan Who Should NOT Join This Trial: 1. Locally advanced esophageal cancer that can be potentially cured through radical surgical resection or radiotherapy; 2. Esophageal squamous cell carcinoma that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction; 3. There is a risk of perforation after stent implantation in the esophageal or tracheal cavity; 4. Has received systemic treatment for advanced or metastatic esophageal squamous cell carcinoma in the past; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age ≥18 years old, gender not limited; 2. Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous carcinoma mixed type and other pathological types); 3. 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; 4. ECOG 0-1; 5. According to RECIST v1.1, there is at least one measurable lesion; 6. Be capable of providing newly obtained or archived tissue samples for immunohistochemical analysis of PD-L1 expression; 7. The patient's organ functions are normal, with no serious abnormalities in blood, heart, lung, liver or kidney functions, and no immune deficiency diseases. 8. The patient has normal coagulation function and no active bleeding or thrombotic diseases. 9. Expected survival time ≥12 weeks; 10. 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. 11. Voluntarily sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan Exclusion Criteria: 1. Locally advanced esophageal cancer that can be potentially cured through radical surgical resection or radiotherapy; 2. Esophageal squamous cell carcinoma that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction; 3. There is a risk of perforation after stent implantation in the esophageal or tracheal cavity; 4. Has received systemic treatment for advanced or metastatic esophageal squamous cell carcinoma in the past; 5. 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; 6. Severe infection occurs (CTCAE\>grade 2), or active pulmonary inflammation; 7. Previous or current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung function impairment; 8. Patients with active tuberculosis infection; 9. 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; 10. 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; 11. There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. 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; 13. 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); 14. 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). 15. Female patients who are pregnant or breastfeeding; 16. Any serious or uncontrolled systemic disease that researchers believe may increase the risk of participation in patients

Treatments Being Tested

DRUG

Iparomlimab and Tuvonralimab combined with chemotherapy

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;

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07290010), the sponsor (Hebei Medical University Fourth Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07290010 clinical trial studying?

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 una… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07290010?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07290010?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07290010. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07290010. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.