A Phase 2 interventional study of Iparomlimab and Tuvonralimab (QL1706)Injection and Paclitaxel in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the perioperative treatment with QL1706 in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma. The primary objective of the Phase II is to evaluate the pathological complete response rate of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma; the primary objective of the Phase III is to compare event-free survival of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy versus placebo in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
Drug: Iparomlimab and Tuvonralimab (QL1706)Injection · Drug: Paclitaxel · Drug: Cisplatin
PD-1/CTLA-4
Chemotherapy
Chemotherapy
Pathologic complete response rate (pCR) as assessed by the investigator; (Phase II stage)
pCR rate was defined as the percentage of subjects with no tumor residue in the primary tumor and regional lymph nodes.
Time frame: 30 days after operation
Event-Free Survival (EFS) as assessed by BIRC; (Phase III stage)
EFS is defined as the time from randomization (for Phase II: from first dose) to the occurrence of an imaging disease progression/recurrence or death event from any cause, whichever occurs first.
Time frame: up to 5 years
No study locations are listed for this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Qilu Pharmaceutical Co., Ltd.