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

March 30, 2026 updated by: Fenglin Liu, Fudan University

Conversion Therapy of Sintilimab Combined With Bevacizumab and XELOX/SOX for Initially Unresectable AFP-positive Gastric/Esophagogastric Junction Adenocarcinoma : A Multi-center, Single-arm, Phase II Trial (SOLIDS-02)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;
  • Adequate organ function
  • ECOG 0-1, no surgery contraindications;
  • Expected survival ≥3 months;

Exclusion Criteria:

  • 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

    --Current treatment with anti-viral therapy or HBV

  • Pregnancy or breastfeeding
  • History of malignancy within 5 years prior to screening
  • Present or history of any autoimmune disease or immune deficiency;
  • There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sintilimab, bevacizumab and chemotherapy (XELOX/SOX)
Sintilimab: 200mg, ivdrip, d1, q3w; Bevacizumab:7.5mg/kg，iv drip，d1, q3w; XELOX:Oxaliplatin+ Capecitabine Capecitabine: 1000mg/m2 twice daily, d1-14, q3w Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; SOX: Oxaliplatin+S-1 S-1:40~60mg Bid, d1~14, q3w Oxaliplatin: 130mg/m2, ivdrip,d1, q3w;
Drug: Oxaliplatin
130mg/m2，iv drip for 2h，d1, q3w
Drug: S-1
40~60mg Bid，d1~14, q3w
Drug: Sintilimab
Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg iv drip，d1, q3w
Drug: Bevacizumab
7.5mg/kg，iv drip，d1, q3w
Drug: Capecitabine
1000mg/m2 twice daily, d1-14, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)
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.
Objective response rate(ORR):CR+PR
From first dose to end of study treatment or last tumor assessment prior to conversion surgery or disease progression.Up to 24 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOLIDS study-02
  • Shanghai Cancer Center (Other Identifier: Fudan University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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