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Stomach NeoplasmsPhase 2PNACGECNCT05033392

PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer

A Phase 2 study testing Toripalimab Injection in people with Stomach Neoplasms, run by Wan He at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Gastric cancer (GC),including cardia and noncardia gastric cancer, is responsible for over 480,000 new cases in 2020 and an estimated 370,000 deaths, making it the third most frequently diagnosed cancer and the third leading cause of cancer death in China. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
Toripalimab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesChina
Study dates
14 Sep 2021to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 yeas and ≤79 years. The gender is not limited.
  • Confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination.
  • Endoscopic ultrasonography and/or enhanced CT/MRI examination confirmed at the stage of cT3/4a Nx or T2 N1-3, M0(AJCC 8th) before randomization.
  • At least 15 unstained sections of formalin-fixed paraffin-embedded tumor tissue sections or fresh tumor tissues can be provided for PD-L1, TMB, tumor infiltrating T lymphocytes, MSI-H/dMMR and EBV detection.
  • The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1
  • Adequate bone marrow and organ function meets the following criteria:
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  • Neutrophil count (ANC)≥1.5×l09/L
  • Platelet (PLT) ≥80×109/L
  • Hemoglobin (Hb) level ≥9.0 g/L
  • Total bilirubin level≤1.5×ULN
  • Alanine aminotransferase (ALT) level≤3×ULN
  • Aspartate aminotransferase (AST) level ≤3×ULN
  • International normalized value (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN
  • Serum creatinine (Cr) level ≤1.5×ULN
  • Creatinine clearance >50 ml/min (Calculated according to the Cockcroft-Gault formula)

Who cannot join

  • Patients with a history of severe hypersensitivity to other monoclonal antibodies or any component of toripalimab injection (JS001).
  • Preoperative pathology diagnosed as squamous cell carcinoma or neuroendocrine tumor.
  • Patients have experienced or currently have other malignancies within 5 years.
  • Patients have received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA4 agent.
  • Patients with history of autoimmune disease; patients with autoimmune-related hypothyroidism receive stable doses of thyroid hormone replacement therapy Eligible to participate in this study; Type 1 diabetes patients who are controlled after receiving a stable insulin treatment plan are eligible to participate in this study;
  • Patients have received systemic immunostimulatory drug therapy (including but not limited to interferon or IL-2) within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is shorter);
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  • Patients who have undergone allogeneic bone marrow transplantation or solid organ transplantation in the past;
  • Active infections, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB examination according to local medical routines), hepatitis B {known HBV surface antigen (HBsAg) positive, and HBV DNA ≥1000cps/ml}, hepatitis C or human immunodeficiency virus (HIV antibody positive).
  • Patients with previous or cured HBV infection (defined as hepatitis B core antibody [anti-HBc] positive and HbsAg negative) are only eligible to participate in this study when HBV DNA is negative (HBV DNA ˂1000cps/ml).
  • Patients with positive hepatitis C (HCV) antibodies are only eligible to participate in this study if the polymerase chain reaction shows negative HCV RNA.
  • There is a serious neurological or mental illness, including dementia and seizures.
  • Suffer from NCI-CTCAE ≥ Grade 2 peripheral neuropathy.
  • Women who are pregnant or breastfeeding.
  • Chronic bowel disease or short bowel syndrome.
  • Those who are deficient in the enzyme dihydropyrimidine dehydrogenase (DPD).
  • Major cardiovascular diseases, such as New York Heart Association heart disease (level II or higher), myocardial infarction within 3 months before randomization, unstable arrhythmia, or unstable angina.
  • Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction <50% must adopt an optimized and stable medical plan determined by the treating doctor. If necessary, you can consult a cardiologist.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wan He, PhD contact

+8618823719462

hewanshenzhen@hotmail.com

Wenwen Li, PhD contact

+8622948111 ext. 5068

wenwenlee@live.cn

China2 sites, 2 recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

    Wan He, PhD, 8675522948111 ext. 5075, hewanshenzhen@hotmail.com

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

    Wan He, PhD,MD

    Recruiting

Other trials in China

About this study

Official title: An Open, Single-center, Phase II Clinical Trial Evaluating the Efficacy of PD-1 Antibody (JS001) in Combination With Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer

Gastric cancer (GC),including cardia and noncardia gastric cancer, is responsible for over 480,000 new cases in 2020 and an estimated 370,000 deaths, making it the third most frequently diagnosed cancer and the third leading cause of cancer death in China. Majority of patients(63%) are presented with locally advanced gastric cancer (stage Ⅱ/Ⅲ) and the prognosis is poor. Previous studies have shown that patients with pathological complete response(pCR) following neoadjuvant therapy have longer survival. In 2019, Lancet Oncology published the FLOT4-AIO study which testified that perioperative chemotherapy with FLOT (5-FU/LV, oxaliplatin and docetaxel) regimen has improved pCR rate and prolonged progression free survival(PFS) and overall survival(OS) in patients with stage II/III gastric cancer. Moreover, PD-1 blockade such as nivolumab or pembrolizumab in combination with chemotherapy has shown higher objective response rate(ORR) as compared to chemotherapy alone in advanced gastric cancer. The nanoparticle albumin-bound paclitaxel has been recommended as the second-line chemotherapy for unresectable or recurrent gastric cancer based on the Chinese Society of Clinical Oncology(CSCO) guideline. When PD-1 antibody is applied, albumin-bound paclitaxel is considered as a better partner since no pretreatment of corticosteroids is needed. Thus, the investigators plan to conduct a phase II clinical trial to evaluate the efficacy and safety of toripalimab (PD-1 antibody) combined with the FLOAP (albumin-bound paclitaxel, oxaliplatin, fluorouracil and leucovorin) regimen as the perioperative treatment of cT2-4 and/or N+ GC. The primary end point is pCR rate. The secondary end points include disease free survival(DFS), OS, ORR, R0 resection rate, incidence of adverse events(AE).

Read the detailed description

This phase Ⅱ trial is a single-arm, open-label, non-randomized and single center clinical study. Patients who met the inclusion criteria will receive the combination of toripalimab (160mg, iv, d1,q2w) with FLOAP (fluorouracil,2600mg/m2; leucovorin, 200mg/m2; oxaliplatin, 85mg/m2; albumin paclitaxel, 150mg/m2, d1, q2w) up to four cycles. After the fourth cycle of the treatment, the clinical efficacy and operation feasibility will be evaluated by the MDT discussions. And then, surgery will be performed within 4 weeks. After the surgery, patients will receive 4-cycle treatments of toripalimab combined with FLOAP regimen. The primary end point is pCR rate. The secondary end points included DFS, OS, ORR, R0 resection rate, incidence of AE.

Being tested
Toripalimab Injection
Keywords
PD-1 antibody, neoadjuvant chemotherapy, gastric cancer, gastroesophageal junction cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Toripalimab InjectionDrug

    Also called JS001

    A domestic PD-1 antibody

Study groups in NCT05033392
Study groupRoleWhat they receive
Toripalimab groupExperimentalToripalimab is administrated with160mg and repeated every 2 weeks.
Receives: Drug: Toripalimab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate

    The proportion of patients with no tumor cells in the postoperative specimens

    Measured: Up to 6 months

Secondary outcomes (5)

  1. Disease Free Survival

    Time from the date of treatment administration until the date of the first documented event of: disease recurrence following surgery (preferably biopsy proven), or death - whichever occurs first

    Measured: Up to 5 years

  2. Overall Survival

    Overall survival is defined as time from the date of treatment administration until the date of death from any cause.

    Measured: Up to 5 years

  3. Objective Response Rate

    The rate of participants that achieve either a complete response (CR) or a partial response (PR).

    Measured: Up to 6 months

  4. R0 Resection Rate

    Rate of microscopically margin-negative resection

    Measured: Up to 6 months

  5. Incidence of Adverse Events

    Number of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2021
  2. Study start14 Sep 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033392
Sponsor's protocol ID
PNACGEC
Acronym
PNACGEC
Status last verified
Feb 2025
First submitted
3 Aug 2021
Last updated
5 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab Injection in people with Stomach Neoplasms, run by Wan He at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wan He, PhD (+8618823719462, hewanshenzhen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05033392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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