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Tests treatment safety and results for Esophageal Squamous Cell Carcinoma (ESCC)
Official title The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07290010
What this study is testing
What is Iparomlimab and Tuvonralimab combined with chemotherapy?
Iparomlimab and Tuvonralimab combined with chemotherapy is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for esophageal squamous cell carcinoma (escc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old, gender not limited;
- Unresectable, recurrent or advanced metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous...
- For patients who have previously received adjuvant/neoadjuvant chemotherapy/chemoradiotherapy, or radical concurrent chemoradiotherapy , the time...
- ECOG 0-1;
- According to RECIST v1.1, there is at least one measurable lesion;
You likely can't join if
- 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 treatment treatment to relieve the...
- 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...
- Severe infection occurs (CTCAE\>grade 2), or active pulmonary inflammation;
See the full eligibility criteria
- 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;
- 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 people 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...
- Voluntarily sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan
- 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 treatment 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...
- Severe infection occurs (CTCAE\>grade 2), or active pulmonary inflammation;
- Previous or current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung function impairment;
- Patients with active tuberculosis infection;
- Participate in another treatment clinical study simultaneously, unless participating in an observational (non-treatment) clinical study or being in the follow-up stage of an treatment 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...
- 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...
- Female patients who are pregnant or breastfeeding;
- Any serious or uncontrolled systemic disease that researchers believe may increase the risk of participation in patients
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.