Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
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
| Verified date | July 2023 |
| Source | Shanghai Junshi Bioscience Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 663 |
| Est. completion date | May 12, 2027 |
| Est. primary completion date | May 12, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Anyang Cancer Hospital | Anyang | Henan |
| China | Beijing Cancer Hospital | Beijing | |
| China | Peking University Third Hospital | Beijing | |
| China | The General Hospital of People's Liberation Army | Beijing | |
| China | The Firest Affiliated Hospital of bengbu Medical College | Bengbu | Anhui |
| China | China-Japan Union hosptial of Jilin university | Changchun | Jilin |
| China | Hunan provincial cancer hospital | Changsha | Hunan |
| China | Heping Hospital Affiliated to changzhi Medical College | Changzhi | |
| China | Sichuan Cancer Hospital & Institute | Chengdu | |
| China | Fujian Cancer Hospital | Fuzhou | |
| China | 3201 Hospital | Hangzhou | |
| China | Zhejiang Cancer Hospital | Hangzhou | |
| China | The First Affiliated Hospital, Zhejiang University School of Medicine | Hanzhou | |
| China | harbin medical university Cancer Hospital | Harbin | |
| China | Anhui Provincial Cancer Hospital | Hefei | |
| China | Anhui provincial hospital | Hefei | Anhui |
| China | The Second Hospital of anhui Medical University | Hefei | Anhui |
| China | Huai'an First People's Hospital | Huai'an | |
| China | Jiangmen central Hospital | Jiangmen | Guangdong |
| China | The Affiliated Hospital of jining Medical University | Jining | |
| China | The first affiliated hospital of jinzhou medical university | Jinzhou | Niaoning |
| China | The First Affiliated Hospital of nanchang University | Nanchang | |
| China | Jiangsu Cancer Hospital | Nanjing | |
| China | Hwa Mei Hospital,University of Chinese Academy of sciences | Ningbo | Zhejiang |
| China | The Affiliated Hospital of Qingdao University | Qingdao | |
| China | Zhongshan Hospital Fudan University | Shanghai | |
| China | Shantou University Cancer Hospital | Shantou | |
| China | Liaoning cancer hospital& Institute | Shenyang | |
| China | Shengjing Hospital of China Medical University | Shenyang | |
| China | The first Hospital of china Medical University | Shenyang | |
| China | Shenzhen people's hosptial | Shenzhen | Guangdong |
| China | The fourth hospital of hebei medical university | Shijiazhuang | Hebei |
| China | Shanxi provincial cancer hosptial | Taiyuan | Shanxi |
| China | Taizhou hospital of zhejiang province | Taizhou | Zhejiang |
| China | Tianjin Medical University Cancer Institute and Hospital | Tianjin | |
| China | Affiliated Tumor Hospital of Xinjiang Medical University | Ürümqi | Xinjiang |
| China | Hubei Cancer Hospital | Wuhan | |
| China | Renmin Hospital of Wuhan University | Wuhan | |
| China | Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | |
| China | The First Affiliated Hospital of Xiamen University | Xiamen | |
| China | Zhongshan Hospital Affiliated to Xiamen University | Xiamen | |
| China | The First Affiliated Hospital of xinxiang Medical University | Xinxiang | Henan |
| China | Xinyang central Hospital | Xinyang | |
| China | The Affiliated Hospital of xuzhou Medical University | Xuzhou | |
| China | Yantai yuhuangding Hospital | Yantai | |
| China | Henan Cancer Hospital | Zhengzhou | |
| China | Henan provincial pepples hospital | Zhengzhou | Henan |
| China | The first affilated hospital of zhengzhou university | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Junshi Bioscience Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | pathologically complete remission (pCR) rate | To compare the percentage of patients who achieved pCR in the 2 arms, pCR rate was defined as the percentage of subjects who achieved a complete pathological response (PCR) | 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 | Investigator-assessed EFS according to RECIST v1.1 | To compare Investigator-assessed events-free survival (EFS) in 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. | 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 | Overall survival | To compare Overall survival in 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. | 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 | 1-year OS rate | To compare 1-year OS rates in 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 | from randomization to death from any cause at 1 year | |
| Secondary | 3- year OS rate | To compare 3-year OS rates in 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 | from randomization to death from any cause at 3 year | |
| Secondary | 5- year OS rate | To compare 5-year OS rates in 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 | from randomization to death from any cause at 5 year |