Study of Neoadjuvant Nivolumab or Placebo Plus Chemotherapy Followed by Surgery and Adjuvant Treatment in Subjects With Resectable ESCC

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT05213312
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab, 360mg intravenous infusion (ivgtt.), on DAY1, Q3W for two cycles;
  • Cisplatin — DRUG
    80 mg/m2 on DAY2 with paclitaxel, Q3W or 80 mg/m2 on DAY1, Q3W ivgtt for two cycles
  • Paclitaxel — DRUG
    175 mg/m2 on DAY2, with cisplatin Q3W, ivgtt for two cycles
  • 5Fluorouracil — DRUG
    800 mg/m2 on DAYS1-5 with cisplatin, Q3W for two cycles
  • Esophagectomy (minimally invasive) — PROCEDURE
    4-6 weeks after neoadjuvant therapy.

Study Details

Esophageal cancer, the 7th most common cancer globally, accounts for more than half a million deaths each year. The incidence of ESCC, the most common histologic type, has been stable, whereas the incidences of esophageal and gastroesophageal junction adenocarcinomas continue to increase in Western countries. Neoadjuvant chemoradiotherapy followed by surgery has become a standard of care for patients with locally advanced resectable esophageal or junctional cancer, especially in western countries. In Asia, nCT is considered as the standard of care for Stage II/III ESCC based on JCOG9204 and JCOG9907 trials. The superiority of nCRT/nCT, in terms of long-term survival, remains to be elucidated. For Stage II/III ESCC patients with multiple stations of lymph nodes involvement, nCT might be more appropriate for the inaccessibility of radiotherapy. There are only limited studies on preoperative immune checkpoint inhibitor in combination with chemotherapy followed by surgery for the locally advanced ESCC. Therefore, this study intends to use Nivolumab 360 mg Q3W combined with standard chemotherapy as the neoadjuvant therapy regimen.

Key Dates

Start date
Jun 1, 2022
Status verified
Jun 2022
Primary completion
Nov 1, 2022
Completion
Mar 1, 2024

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NIT+NCT Group (Arm A)
    1. Neoadjuvant immunotherapy : Nivolumab, 360mg intravenous infusion (ivgtt.), on DAY1, Q3W for two cycles; 2. Neoadjuvant chemotherapy (investigator's choice) : Cisplatin, 80 mg/m2 and Paclitaxel, 175 mg/m2 on DAY2, Q3W Or Cisplatin, 80 mg/m2 on DAY1 and 5-fluorouracil, 800 mg/m2 on DAYS1-5, Q3W for two cycles. All given intravenously. 3. MIE : Esophagectomy plus two/three field lymphadenectomy, 4-6 weeks after neoadjuvant therapy. 4. Adjuvant immunotherapy : 4-6 weeks after operation, (for subjects with non-pCR) Nivolumab injection, 240mg intravenous infusion, Q2W for 16 weeks, followed by 480mg intravenous infusion, Q4W. The maximum duration of adjuvant Nivolumab therapy is one year.
  • Placebo Comparator: NCT Group (Arm B)
    1. Placebo: NS ivgtt (dose, frequency and duration same as the Nivolumab); 2. Neoadjuvant chemotherapy (investigator's choice) : Cisplatin, 80 mg/m2 and Paclitaxel, 175 mg/m2 on DAY2, Q3W Or Cisplatin, 80 mg/m2 on DAY1 and 5-fluorouracil, 800 mg/m2 on DAYS1-5, Q3W for two cycles. All given intravenously. 3. MIE : Esophagectomy plus two/three field lymphadenectomy, 4-6 weeks after neoadjuvant therapy. 4. Adjuvant immunotherapy : 4-6 weeks after operation, (for subjects with non-pCR) Nivolumab injection, 240mg intravenous infusion, Q2W for 16 weeks, followed by 480mg intravenous infusion, Q4W. The maximum duration of adjuvant Nivolumab therapy is one year.

Primary Outcome Measure

Pathological Complete Response (pCR) rate [ Time Frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months ]

Central Contacts

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