Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Conditions
Brief 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.
Interventions
COMBINATION_PRODUCTToripalimab combined with cisplatin and paclitaxel
Specified doses on specified days.
COMBINATION_PRODUCTPlacebo combined with cisplatin and paclitaxel
Specified doses on specified days.
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| 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 | 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. |
| 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 | 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. |
| 1-year OS rate | from randomization to death from any cause at 1 year | 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 |
| 3- year OS rate | from randomization to death from any cause at 3 year | 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 |
| 5- year OS rate | from randomization to death from any cause at 5 year | 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLin Shen
Peking University Cancer Hospital & Institute
PRINCIPAL_INVESTIGATORYongtao Han
Sichuan Cancer Hospital and Research Institute
PRINCIPAL_INVESTIGATORYan Zheng
Henan Cancer Hospital
PRINCIPAL_INVESTIGATORKeneng Chen
Peking University Cancer Hospital & Institute
Outcome results
None listed