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PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

ConditionsSquamous Cell Esophageal CarcinomaEsophageal CancerOesophageal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.

Patients must not have received any prior anticancer therapy.

More than 6 months of expected survival.

Age ranges from 18 to 70 years.

Disqualifiers

Patients have received any prior anticancer therapy.

Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.

Patients with concomitant hemorrhagic disease.

Patients who cannot tolerate surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab

    Drug

    Sintilimab 200mg, IV (in the vein) on day 1 and day 22

  • Preoperative radiotherapy

    Radiation

    External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.

  • Paclitaxel

    Drug

    50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22

  • Cisplatin

    Drug

    25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22

  • esophagectomy

    Procedure/Surgery

    McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.

Treatment groups

422 Participants
are divided into 2 treatment groups
Group A: NCRT+IO groupExperimental treatment 5 interventions
Group B: NCRT groupActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Overall survival will be calculated from the date of randomization and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.

Time frame
At end of enrollment- up to 5 years in follow up

Secondary outcomes

1

Progression free survival

Progression free survival is defined as the time from randomization until objective tumor progression or death.

Time frame
At end of enrollment- up to 5 years in follow up
2

Pathologic complete response rate

No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes

Time frame
Two weeks after surgery
3

R0 resection rate

The percentage of patients who undergo complete resection

Time frame
Two weeks after surgery
4

Incidence of perioperative complications

Incidence of complications

Time frame
Ninety days after surgery

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Affiliated Cancer Hospital of Shantou University Medical College

Collaborator

Source ClinicalTrials.gov
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