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

NCT ID: NCT06852456

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2034-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QL1706 injection combined with chemotherapy

Group Type EXPERIMENTAL

Iparomlimab and Tuvonralimab (QL1706)Injection

Intervention Type DRUG

PD-1/CTLA-4

Paclitaxel

Intervention Type DRUG

Chemotherapy

Cisplatin

Intervention Type DRUG

Chemotherapy

Interventions

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Iparomlimab and Tuvonralimab (QL1706)Injection

PD-1/CTLA-4

Intervention Type DRUG

Paclitaxel

Chemotherapy

Intervention Type DRUG

Cisplatin

Chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Lin Shen, M.D

Role: CONTACT

Phone: 010-88196340

Email: [email protected]

Other Identifiers

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QL1706-305

Identifier Type: -

Identifier Source: org_study_id