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Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesophageal Junction Adenocarcinoma

ConditionsGastric Cancer (GC)AFP Gastric or Gastroesophageal Junction Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Not only does it show abnormally elevated serum AFP levels, but it also has a stronger angiogenic ability, a higher rate of distant metastasis, and a poorer prognosis even after a upfront R0 surgery, making it a challenging problem in the field of gastric cancer treatment. Notably, patients with AFP-positive gastric cancer have a relatively low sensitivity to the traditional standard regimens. There is an urgent need to explore targeted treatment strategies to break through the efficacy bottleneck.

Combination of sintilimab, bevacizumab and XELOX/SOX for initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a multi-center, single-arm phase 2 clinical trial to evaluate efficacy, tolerability and safety of perioperative sintilimab in combination with bevacizumab and XELOX/SOX in initially unresectable AFP-positive gastric/esophagogastric junction adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent;

Patients age 18-75 years;

Histologically CT/MRI confirmed cT3-4N+M0/1 gastric or GEJ adenocarcinoma; (M1 only includes type I liver metastasis of gastric cancer, according to the "Chinese Expert Consensus on Liver Metastasis of Gastric Cancer");

Serum AFP levels > 2× upper limit of normal or AFP-positive by IHC staining;

Disqualifiers

HER2-positive status: IHC 3+, or IHC 2+/FISH+

Prior chemotherapy, radiotherapy, anti-PD-1/PD-L1 therapy, surgery for gastric cancer;

Signs of other distant metastases (e.g., peritoneal, lung, bone, supraclavicular lymph, etc.)

Significant cardiovascular disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Sintilimab

    Drug

    Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg iv drip，d1, q3w

  • Bevacizumab

    Drug

    7.5mg/kg，iv drip，d1, q3w

  • Oxaliplatin

    Drug

    130mg/m2，iv drip for 2h，d1, q3w

  • Capecitabine

    Drug

    1000mg/m2 twice daily, d1-14, q3w

  • S-1

    Drug

    40\~60mg Bid，d1\~14, q3w

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Sintilimab, bevacizumab and chemotherapy (XELOX/SOX)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Objective response rate(ORR)

Objective response rate(ORR):CR+PR

Time frame
From first dose to end of study treatment or last tumor assessment prior to conversion surgery or disease progression.Up to 24 weeks.

Secondary outcomes

1

R0 resection rate

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation.Up to 24 weeks.
2

Major pathological response rate

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation.Up to 24 weeks.
3

One year progression-free survival (PFS)

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 1 year.
4

One year overall survival(OS)

Time frame
The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date,assessed up to 1 year.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

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