New drug combo aims to fight advanced esophageal cancer
NCT ID NCT07290010
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether two immunotherapy drugs (iparomlimab and tuvonralimab) plus chemotherapy can help people with advanced esophageal cancer that has come back or spread. About 25 adults will receive the treatment for up to 24 months. The goal is to see if the combination shrinks tumors and controls the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hebei Medical University Fourth Hospital
RECRUITINGShijiazhuang, Hebei, 050000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Why does esophageal cancer come back after treatment? researchers search medical records for clues
- Which Pre-Surgery combo extends life in esophageal cancer? a virtual trial seeks answers
- Can an AI eye guide surgeons to safer, faster cancer removal?
- Can a triple punch of immunotherapy and chemoradiation wipe out esophageal tumors before surgery?
- Can early tumor response guide smarter cancer treatment?
- Could a smart combo of drugs and radiation help some esophageal cancer patients skip surgery?