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Sintilimab Plus NCT or NCRT Versus NCRT for ESCC

ConditionEsophageal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Cancer Hospital and Research Institute

About this trial

Comparative analysis of patients with resectable locally advanced esophageal squamous cell carcinoma treated with neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy combined sintilimab versus neoadjuvant chemoradiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75, both sexes;

Patients with histologically confirmed locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM stage);

Cervical contrast-enhanced CT showed no suspicious metastatic lymph nodes. Imaging examination showed no systemic metastasis.

R0 resection is expected to be achieved;

Disqualifiers

Malignant tumors other than esophageal cancer (cured localized tumors, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, were not excluded) had occurred within 5 years before randomization; Prostate cancer patients receiving hormone therapy with DFS for more than 5 years were not excluded).

Patients with high blood tendency who had a history of gastrointestinal bleeding within 6 months before randomization, or had coagulopathy at the time of enrollment, or were receiving thrombolysis or anticoagulant therapy;

Previous history of interstitial lung disease or pneumonia requiring steroid treatment at enrollment;

Had active tuberculosis at the time of randomization, or had received anti-tuberculosis therapy within 1 year before randomization;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab

    Drug

    Sintilimab: D1 administration) for 2 cycles. Every 3 weeks was a dosing cycle (Q3W)

  • radiotherapy

    Radiation

    Radiotherapy: According to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week.

  • Chemotherapy

    Drug

    Neoadjuvant chemotherapy with TP regimen: albumin-paclitaxel + carboplatin, D1 administration) for 2 cycles. Every 3 weeks was a dosing cycle (Q3W).

Treatment groups

420 Participants
are divided into 3 treatment groups
Group A: Group of sintilimab combined with neoadjuvant chemotherapyExperimental treatment 2 interventions
Group B: Group of sintilimab combined with neoadjuvant chemoradiotherapyExperimental treatment 3 interventions
Group C: Group of neoadjuvant chemoradiotherapyOther 2 interventions

Trial outcomes

Primary outcomes

1

Pathology complete response rate, pCR

Definition of pathology complete response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0 definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders".

Time frame
3 months after the surgery

Secondary outcomes

1

Treatment related adverse event, TRAE

The TRAE defined as the proportion of participants who have treatment-related adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Event, Version 4.0 (CTCAE v4.0).

Time frame
3 months after the surgery
2

Major Pathological Remission rate, MPR

The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline.

Time frame
3 months after the surgery
3

Rate of R0 resection

Measure the rate of R0 resection with all margins microscopically clear.

Time frame
3 months after the surgery
4

Events Free Survival, EFS

Event-free survival was defined as the time from the date of randomization to the date of the first documented non-fatal event (worsening cardiac function, hospitalization for congestive heart failure, liver function impairment, liver cirrhosis, transformation to AML, as defined in the protocol), or death, whichever occurred first. Participants who did not experience a non-fatal event as of the time of data cut-off (end of study), as well as participants who did not experience a non-fatal event and stopped study participation before the data cut-off, were censored as specified in the protocol.

Time frame
Through study completion, an average of 1 year.

Other outcomes

Sponsors and contacts

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Sichuan Cancer Hospital and Research Institute

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

Anhui Provincial Hospital

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Anyang Tumor Hospital

Collaborator

Shantou Central Hospital

Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

Collaborator

GeneCast Biotechnology Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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