ClinicalTrials.gg
Status unknownNCT06396585Updated May 7, 2024

The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction

A Phase 2 interventional study of Tislelizumab and Anlotinib in Immunotherapy Gastroesophageal Junction, sponsored by Fujian Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Fujian Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer

02

Conditions studied

  • Immunotherapy Gastroesophageal Junction
03

In context

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 162 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female and male patient ≥ 18 and ≤ 75 years.
  • Histologically confirmed, medically operable, resectable adenocarcinoma of the gastroesophageal junction (AEG, Siewert II-III),uT3, uT4a, uT4b any N category, M0, or any T N+ M0 patient
  • ECOG≤1
  • No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
  • Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs).
  • Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
  • The expected survival time is more than 6 months.
  • Women of childbearing age shall be those who agree to use contraception (such as intrauterine devices, contraceptives or condoms) during the study and for 6 months after the end of the study; those who have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating; and men who agree to use contraception during the study and for 6 months after the end of the study.
  • Hematological, hepatic and renal function parameters adequate to allow surgical procedure and chemotherapy
  • Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
  • Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed, if it was still positive after reexamination, gastroscopy was required.
  • Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
  • A history of immunodeficiency, including HIV testing positive.
  • Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
  • Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
  • HER2 positive is known.
  • Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Tislelizumab combined with anlotinib chemotherapy

    Drug: Tislelizumab · Drug: Anlotinib · Drug: Oxaliplatin · Drug: Tegafur

Interventions

  • Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 ,Q3W

  • Participants will receive anlotinib,12mg, qd,d1-d14,Q3W

  • Participants will receive Oxaliplatin, 130mg/m2, iv, day 1 ,Q3W

  • Participants will receive S-1 40-60mg/m2/c次,bid ,d1-d14,Q3W

06

What researchers measure

Primary outcomes

  1. Pathological complete response

    Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

    Time frame: 4 weeks after surgery

Secondary outcomes

  1. Major pathological response

    Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

    Time frame: 4 weeks after surgery

  2. Objective Response Rate (ORR)

    Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor

    Time frame: At the end of Cycle 3 (each cycle is 21 days)

07

Study locations

1 site
  • Fujian cancer hospital
    Fuzhou, Fujian 350500, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2024; primary completion for Aug 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2024
First posted
May 2, 2024
StartEst.
Aug 1, 2024
Primary completionEst.
Aug 31, 2025
CompletionEst.
Aug 31, 2026
Last update
May 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06396585
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Aug 1, 2024 (estimated)
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
May 7, 2024

Study contacts

Ye Zai sheng, Doctor
Contact
flyingengel@sina.cn
13950203076 ext. 86

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Tislelizumab · Anlotinib · Oxaliplatin

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