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S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma

ConditionsLocally Advanced Gastroesophageal Junction AdenocarcinomaChemotherapy Effect
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

For locally advanced adenocarcinoma of esophagogastric junction(AEG) (cT3-4aN+M0), neoadjuvant chemotherapy was improved to downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced AEG could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Sintilimab in this study is an anti-PD-1 monoclonal antibody for injection which has been approved for several malignant tumors. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of sintilimab in combination with perioperative chemotherapy in locally advanced AEG.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written (signed) informed consent;

Histologically CT/MRI confirmed cT3-4aN+M0 Esophagogastric Junction Adenocarcinoma;

Consent to send tumor tissue from biopsy or resection for PD-L1, EBV, MSI detection;

Female or male, 18-75 years;

Disqualifiers

Suffer from other active malignant tumors within 5 years or at the same time. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the group.

Patients who are planning to undergo or have previously received organ or bone marrow transplantation.

Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) occurred within 6 months before the first medication (QTc interval is calculated by Fridericia's formula).

There is NYHA standard grade III to IV cardiac insufficiency or color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) <50%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxaliplatin+S-1

    Drug

    Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w Drug: S-1 S-1: 40\~60mg Bid，d1\~14, q3w

  • Sinitilimab+oxaliplatin+S-1

    Drug

    Drug: Sintilimab Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg ivdrip, d1, q3w. Other Name: PD-1 antibody Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w Drug: S-1 S-1: 40\~60mg Bid，d1\~14, q3w

Treatment groups

302 Participants
are divided into 2 treatment groups
Group A: Active ComparatorActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pCR

pathological complete response rate

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Secondary outcomes

1

TRG0/1

Pathological tumor regression grade 0/1

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
2

R0 resection rate

Rate of microscopically margin-negative resection

Time frame
rom the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
3

DFS

the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of first documented symptoms of cancer, assessed up to 3 years
4

RFS

The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented recurrence

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Other outcomes

Sponsors and contacts

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

Sixth Affiliated Hospital, Sun Yat-sen University

Lead sponsor

Sun Yat-sen University

Collaborator

Source ClinicalTrials.gov
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