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NCT Number: NCT06852456

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

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.

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Key information

Conditions

Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iparomlimab and Tuvonralimab (QL1706)Injection

Drug

PD-1/CTLA-4

paclitaxel

Drug

Chemotherapy

Cisplatin

Drug

Chemotherapy

Primary outcomes

  1. Pathologic complete response rate (pCR) as assessed by the investigator; (Phase II stage)

    Time frame: 30 days after operation

    pCR rate was defined as the percentage of subjects with no tumor residue in the primary tumor and regional lymph nodes.

  2. Event-Free Survival (EFS) as assessed by BIRC; (Phase III stage)

    Time frame: up to 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Shen, M.D

CONTACT

[email protected]

010-88196340

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A PhaseⅡ/Ⅲ, Randomized, Double-blind, Placebo-controlled Trial to Evaluate QL1706 Perioperative Treatment in Combination With Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma

Important dates

Study start
2025
Primary completion
2030
Study completion
2034
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.