A Clinical Study of SHR-1701 Combined With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Medical University Fourth Hospital

About this trial

Evaluating the efficacy and safety of SHR-1701 combined with chemotherapy for the perioperative treatment of locally advanced resectable Siewert type II adenocarcinoma of the esophagogastric junction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HB≥90g/L;

ANC≥1.5×109/L;

PLT≥100×109/L;

ALT and AST<2.5ULN(liver metastasis: ALT and AST<5ULN);

Disqualifiers

Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);

Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;

Cardia or pyloric obstruction;

Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-1701+SOX

    Drug

    SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA\<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: SHR-1701+SOXExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pathological Complete Response(pCR)

No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.

Time frame
1-year
2

R0 resection rate

The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.

Time frame
1-year

Secondary outcomes

1

Major Pathological Response(MPR)

Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%.

Time frame
1-year
2

PFS(Progression-Free Survival)

The time from the start of treatment until tumor progression or death from any cause.

Time frame
3 years
3

OS(Overall Survival )

Time from enrollment to death from any cause. For subjects who were still alive at the time of the last follow-up, their overall survival was censored on the date of the last follow-up.

Time frame
3 years

Other outcomes

Sponsors and contacts

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