Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital

About this trial

The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pathological findings suggest compound squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc.

History of subtotal gastrectomy;

accompanied by a second primary cancer;

Tumor metabolic imaging prior to treatment suggested distant metastasis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin

    Drug

    Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: Pembrolizumab Plus Albumin Paclitaxel and CisplatinExperimental treatment 1 intervention
Group B: Pembrolizumab Plus 5-fluorouracil and CisplatinActive comparator 1 intervention
Group C: 5-fluorouracil and CisplatinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pathologic complete response rate (pCR)

Pathologic complete response rate (pCR)

Time frame
up to 4 months

Secondary outcomes

1

Major pathological response(MPR)

Major pathological response(MPR)

Time frame
up to 4 months
2

Event free survival(EFS)

Event free survival(EFS)

Time frame
up to 10 years
3

Overall survival(OS)

Overall survival(OS)

Time frame
up to 10 years

Other outcomes

Sponsors and contacts

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