A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Plain English Summary

Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma is a Phase 3 clinical trial sponsored by Shanghai Junshi Bioscience Co., Ltd. studying Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma. Tests the effectiveness of Toripalimab combined with chemotherapy compared to placebo and chemotherapy in patients with locally advanced thoracic esophageal squamous cell carcinoma. For patients with resectable locally advanced thoracic esophageal squamous cell carcinoma who are expected to undergo R0 resection. Participation involves receiving either Toripalimab or placebo combined with chemotherapy for a specific period before and after surgery. Alternative treatments include standard chemotherapy alone or other immunotherapy options. The trial aims to enroll 663 participants.

Official Summary

This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible patients must have locally advanced thoracic esophageal squamous cell carcinoma confirmed by histology. Patients cannot have other cancers or serious allergies to chemotherapy or monoclonal antibodies. Age range is not specified, but patients must be able to undergo surgery. Health requirements include no systemic metastasis and expected R0 resection. This trial is studying Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the event-free survival, which means how long patients can stay free from disease progression or death. The specific primary outcome measures are: To compare IRC-assessed events-free survival (EFS) in 2 arms (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a significant treatment gap by evaluating a new immunotherapy approach for locally advanced thoracic esophageal squamous cell carcinoma. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, where improved treatment options are needed.

Investor Insight

The market for esophageal cancer treatments is growing, with this trial potentially offering a new option, and the approval probability is high given the phase and design. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 663 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have any other health conditions that might affect your participation. You will receive either Toripalimab or placebo combined with chemotherapy before and after surgery. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: SEQUENTIAL
• Masking: QUADRUPLE
• Enrollment: 663 participants

Interventions

• COMBINATION_PRODUCT: Toripalimab combined with cisplatin and paclitaxel — Specified doses on specified days.
• COMBINATION_PRODUCT: Placebo combined with cisplatin and paclitaxel — Specified doses on specified days.

Primary Outcomes

• To compare IRC-assessed events-free survival (EFS) in 2 arms (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)

Secondary Outcomes

• pathologically complete remission (pCR) rate (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)
• Investigator-assessed EFS according to RECIST v1.1 (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)
• Overall survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)
• 1-year OS rate (from randomization to death from any cause at 1 year)
• 3- year OS rate (from randomization to death from any cause at 3 year)

Full Eligibility Criteria

Patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study:

1. Histologically confirmed locally advanced (T1N1-3M0 or T2-3N0-3M0) squamous cell carcinoma of the thoracic esophagus (per the 8th Edition of UICC-TNM Classification);
2. No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination;
3. Expected to be achievable to conduct R0 resection.

Patients must not enter this study if any of the following exclusion criteria is fulfilled:

1. Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization;
2. Combined with other inoperable condition;
3. Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody;
4. Combined with other conditions unsuitable for participation in this study as judged by investigators.

Other protocol defined Inclusion/exclusion criteria could apply.

Trial Locations

• The Firest Affiliated Hospital of bengbu Medical College, Bengbu, Anhui, China
• Anhui provincial hospital, Hefei, Anhui, China
• The Second Hospital of anhui Medical University, Hefei, Anhui, China
• Jiangmen central Hospital, Jiangmen, Guangdong, China
• Shenzhen people's hosptial, Shenzhen, Guangdong, China
• The fourth hospital of hebei medical university, Shijiazhuang, Hebei, China
• Anyang Cancer Hospital, Anyang, Henan, China
• The First Affiliated Hospital of xinxiang Medical University, Xinxiang, Henan, China
• Henan provincial pepples hospital, Zhengzhou, Henan, China
• The first affilated hospital of zhengzhou university, Zhengzhou, Henan, China
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Related conditions include other types of esophageal cancer, lung cancer, and head and neck cancers.
• Therapeutic areas include oncology, immunotherapy, and thoracic surgery.

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