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

NCT06852456 | Not Yet Recruiting Phase 2

• 1 other identifier: QL1706-305
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  up to 5 years

Study Arms (1)

QL1706 injection combined with chemotherapy

EXPERIMENTAL

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

Interventions

Iparomlimab and Tuvonralimab (QL1706)Injection DRUG

PD-1/CTLA-4

QL1706 injection combined with chemotherapy

Paclitaxel DRUG

Chemotherapy

QL1706 injection combined with chemotherapy

Cisplatin DRUG

Chemotherapy

QL1706 injection combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Paclitaxel; Cisplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Lin Shen, M.D

CONTACT

010-88196340; doctorshenlin@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2034
• Last Updated: February 28, 2025

Record last verified: 2025-02