QL1706 in Combination With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Treatments: Drug: Paclitaxel; Drug: Cisplatin; Drug: Iparomlimab and Tuvonralimab (QL1706)Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06852456

QL1706-305

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
• Patients with thoracic esophageal squamous cell carcinoma diagnosed by pathologic histology or cytology and cT1-2N1-3M0 or cT3-4aN0-3M0 according to AJCC/UICC 8th edition.
• Expected to undergo surgery after completion of neoadjuvant therapy and expected to achieve R0 resection.
• Have not receiv any anti-tumor therapy for esophageal cancer.
• Have adequate organ function.

Exclusion criteria

• Significant tumor invasion into organs adjacent to the esophageal lesion;
• a history of gastrointestinal bleeding or those with a high bleeding tendency;
• The presence of supraclavicular lymph node metastases;
• the presence of uncontrollable third interstitial fluid;
• poor nutritional status.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

QL1706 injection combined with chemotherapy

Experimental group

Treatment:

Drug: Iparomlimab and Tuvonralimab (QL1706)Injection

Drug: Cisplatin

Drug: Paclitaxel