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Status unknownNCT05942573Updated Jul 12, 2023

Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial

A Phase 2 interventional study of Serplulimab+Paclitaxel+Apatinib and Paclitaxel±Ramucirumab in Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ), sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-12.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2022, registered Apr 2023).
Phase
Phase 2
Study type
Interventional
Enrollment
107
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. After PD，patients will randomly 2：1 assigned to treatment：one group will receive Serpluimab with Paclitaxel,Apatinib；another group will receive Paclitaxel with or without Ramucirumab.All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent

Read the detailed description

stage one ：Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+oxaliplatin130mg/m2 iv.gtt d1+capecitabine 1000mg/m2 p.o.b.i.d d1\~d14,q3w

stage two:Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+Apatinib 250mg/qd+Paclitaxel 135\~175mg/m2 iv.gtt,d1,q3w

Paclitaxel 135\~175mg/m2 iv.gtt,d1,q3w±Ramucirumab 8mg/kg,d1,q2w

02

Conditions studied

  • Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 107 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 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

Inclusion criteria

  1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
  2. Age ≥ 18 years and ≤ 75 years when ICF is signed;
  3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
  4. never received systemic anti-tumor drug therapy before；
  5. HER2 negative and PD-L1 CPS≥5;
  6. Measurable lesion according to RECIST v1.1 by IRRC;
  7. ECOG score 0-1;

Exclusion criteria

Exclusion Criteria:

  1. Has other active malignancies within 5 years before the first administration of the study drug;
  2. Plan to or have previously received organ or bone marrow transplantation;
  3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
  4. Have received any research drugs within 14 days before the first use of the study drugs.
05

Study design

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

Study arms

  • Experimental
    continuation of Serplulimab plus chemotherapy after first progression

    Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab

    Drug: Serplulimab+Paclitaxel+Apatinib · Drug: Paclitaxel±Ramucirumab

Interventions

  • DrugSerplulimab+Paclitaxel+Apatinib

    Immunotherapy+chemotherapy

    Also known as: A:Drug:Serplulimab+paclitaxel+Apatinib

  • DrugPaclitaxel±Ramucirumab

    chemotherapy±Targeted therapy

    Also known as: B:Drug:paclitaxel±Ramucirumab

06

What researchers measure

Primary outcomes

  1. 6-month PFS%

    Progression-free survival by IRRC assessment per RECIST 1.1

    Time frame: The Percent of patinets after first progression until disease progression in 6 months

Secondary outcomes

  1. OS

    Overall survival

    Time frame: From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]

  2. PFS2

    Progression-free survival by IRRC assessment per RECIST 1.1

    Time frame: From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first

  3. PFS1

    Progression-free survival by IRRC assessment per RECIST 1.1

    Time frame: From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, Tianjin, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05942573
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
Jul 12, 2023
Start date
Dec 24, 2022
Primary completion
Oct 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 12, 2023

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 Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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