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

NCT ID: NCT07290010

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-26
• Study Completion Date: 2028-06-30

Brief 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). 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.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

immunotherapy; ESCC; PD-1/CTLA-4; Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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;

Group Type: EXPERIMENTAL

Iparomlimab and Tuvonralimab combined with chemotherapy

Intervention Type: DRUG

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;

Interventions

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;

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shengmian Li

Role: CONTACT

Phone: +8613931185237

Email: shengmianli2013@163.com

Facility Contacts

Shengmian Li

Role: primary

Other Identifiers

2025KY012

Identifier Type: -

Identifier Source: org_study_id