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Neoadjuvant Treatment of Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in Esophageal Squamous Cell Carcinoma

ConditionEsophageal Squamous Cell Carcinoma (ESCC)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital

About this trial

This study is a randomized, controlled, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of neoadjuvant toripalimab in combination with nab-paclitaxel and platinum versus neoadjuvant docetaxel in combination with cisplatin and 5-fluorouracil (DCF) in the treatment of resectable locally advanced esophageal squamous cell carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the written informed consent form;

Age 18-75 years, inclusive of 18 and 75 years, both male and female;

Life expectancy of ≥3 months;

Expected to achieve R0 resection;

Disqualifiers

Previous treatment with PD-1/PD-L1 agents or drugs targeting another T-cell receptor (e.g., CTLA-4, OX-40, etc.);

Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;

Active autoimmune disease or suspicion of such, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc., with the exception of type 1 diabetes and hypothyroidism controlled with stable-dose replacement therapy, and skin diseases not requiring systemic treatment (e.g., psoriasis, vitiligo);

History of interstitial lung disease ≥ Grade 2;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3 cycles (Toripalimab + chemotherapy)

    Drug

    Toripalimab: 240mg, intravenous infusion, on Day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Nab-paclitaxel: 125mg/m², intravenous infusion, on Day 1 and Day 8, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Cisplatin: 75mg/m², intravenous infusion, on Day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment;

  • 3 cycles（DCF）

    Drug

    Docetaxel: 70mg/m², intravenous infusion, on day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Cisplatin: 70mg/m², intravenous infusion, on day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; 5-FU (5-fluorouracil): 750mg/m², intravenous infusion, on day 1 to day 5, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: 3 cycles (Toripalimab + chemotherapy)Experimental treatment 1 intervention
Group B: 3 cycles（DCF）Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete response rate (pCR)

Time frame
Pathological detection after surgery within 1 month

Secondary outcomes

1

Major pathological response rate (MPR)

Time frame
Pathological detection after surgery within 1 month
2

objective response rate (ORR)

Time frame
From enrollment to the period before surgery (4-6 weeks after the third cycle of treatment).
3

event-free survival (EFS)

Time frame
from randomization to disease progression that makes surgery impossible, postoperative disease progression, local or distant recurrence, or death from any cause (whichever occurs first，assessed up to 60 months)
4

overall survival

Time frame
from randomization to death from any cause，assessed up to 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: