QL1706 in Combination With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iparomlimab and Tuvonralimab (QL1706)Injection, Paclitaxel, Cisplatin.
- Who it may be relevant to
- Registry conditions: Resectable Locally Advanced Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Drug Iparomlimab and Tuvonralimab (QL1706)Injection
PD-1/CTLA-4 - Drug Paclitaxel
Chemotherapy - Drug Cisplatin
Chemotherapy
Primary outcome measures
- Pathologic complete response rate (pCR) as assessed by the investigator; (Phase II stage) [Time frame: 30 days after operation]
- Event-Free Survival (EFS) as assessed by BIRC; (Phase III stage) [Time frame: up to 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06852456 · QL1706-305