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Sintilimab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Locally Advanced Gastroesophageal Junction Cancer

ConditionGastroesophageal Junction Adenocarcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAnhui Medical University

About this trial

This is a multicenter, prospective, single-arm, open-label exploratory clinical study evaluating sintilimab combined with neoadjuvant chemotherapy, concurrent chemoradiotherapy, and optional consolidation chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma. Eligible participants will receive one cycle of sintilimab plus XELOX induction therapy, followed by sintilimab plus capecitabine concurrent radiotherapy. Optional consolidation with sintilimab plus XELOX may be administered according to treatment response, toxicity recovery, nutritional status, surgical feasibility, and multidisciplinary team assessment. Patients who are considered suitable for surgery will undergo radical resection and regional lymph node dissection. The primary endpoint is pathological complete response rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years, regardless of sex, willing to participate in the study and able to provide written informed consent.

Disqualifiers

Patients considered unsuitable by the multidisciplinary team for neoadjuvant chemoradiotherapy, immunotherapy, or subsequent radical surgery.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sintilimab

    Drug

    Oxaliplatin 130 mg/m² administered by intravenous infusion on Day 1 of a 21-day cycle during induction and optional consolidation XELOX treatment.

  • Capecitabine

    Drug

    During induction and optional consolidation XELOX treatment, capecitabine is administered at 1000 mg/m² orally twice daily on Days 1-14 of each 21-day cycle. During concurrent chemoradiotherapy, capecitabine is administered at 825 mg/m² orally twice daily on radiotherapy days as a radiosensitizer.

  • Oxaliplatin

    Drug

    Oxaliplatin 130 mg/m² administered by intravenous infusion on Day 1 of a 21-day cycle during induction and optional consolidation XELOX treatment.

  • Radiation

    Radiation

    Intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) to the primary tumor and regional lymphatic drainage areas, with a total dose of 45 Gy in 25 fractions, administered 5 days per week for 5 weeks.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Neoadjuvant Sintilimab-Based Multimodal TherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response Rate

Pathological complete response is defined as no viable tumor cells identified in the primary tumor and regional lymph nodes in the surgical resection specimen after neoadjuvant treatment, corresponding to ypT0N0. The pCR rate is defined as the proportion of participants achieving pCR among participants included in the primary efficacy analysis set.

Time frame
At the time of definitive surgery after completion of neoadjuvant treatment

Secondary outcomes

1

Major Pathological Response Rate

Time frame
At definitive surgery
2

Tumor Regression Grade

Time frame
At definitive surgery
3

Pathological Downstaging Rate

Time frame
At definitive surgery
4

R0 Resection Rate

Time frame
At definitive surgery

Other outcomes

Sponsors and contacts

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

Anhui Medical University

Lead sponsor

The Second Hospital of Anhui Medical University

Collaborator

Suzhou Municipal Hospital

Collaborator

First Affiliated Hospital of Wannan Medical College

Collaborator

Fuyang people's hospital

Collaborator

Source ClinicalTrials.gov

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