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Efficacy and Safety of Sintilimab Combined With Nab-paclitaxel and Tegio (aTS) as First-line Treatment of Unresectable Locally Advanced, Recurrent or Metastatic Adenocarcinoma of Gastric and Gastroesophageal Junction，a Phase II Clinical Study

ConditionsGastric CancerGastroEsophageal CancerAdenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWu Jun

About this trial

The goal of this clinical trial is to find better protocal for adenocarcinoma of the gastric and gastroesophageal juncion.

The main question is aim to answer is:

1\. The efficacy and safety of PD-1 monoclonal antibody (Sintilimab) combined with nab-paclitaxel and S-1 in the first-line treatment of advanced gastric and gastroesophageal junction adenocarcinoma.

Participants will be given PD-1 monoclonal antibody, nab-paclitaxel and tegio.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non resectable locally advanced, recurrent, or metastatic adenocarcinoma at the junction of the stomach and esophagus (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) confirmed by histopathological examination.

Age ≥ 18 years old.

The ECOG PS score is 0 or 1.

The time from the end of previous (new) adjuvant chemotherapy/radiotherapy to disease recurrence is greater than 6 months.

Disqualifiers

Known signs of active bleeding in the lesion (excluding positive fecal occult blood).

Obstruction of the cardia and pylorus can affect the patient's eating and gastric emptying, or hinder the swallowing of medication.

Diagnosed as HER2 positive adenocarcinoma at the junction of the stomach and esophagus.

Previously received systematic treatment for advanced or metastatic adenocarcinoma at the junction of the stomach and esophagus.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sintilimab,nab-paclitaxel and tegio

    Drug

    Immunotherapy combined with chemotherapy

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Experimental ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

Time frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
2

Objective response rate (ORR)

Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

Time frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

Secondary outcomes

1

Overall survival (OS)

Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

Time frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
2

Disease control rate (DCR)

Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

Time frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
3

Disease control rate (DOR)

Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

Time frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

Other outcomes

Sponsors and contacts

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

Wu Jun

Lead sponsor

The First People's Hospital of Changzhou

Sponsor institution

Source ClinicalTrials.gov

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