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Gastric CancerPhase 3NCT04997837

Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma

A Phase 3 study testing PD-1 inhibitor, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Fudan University at 1 site 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
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Trial summary

The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
PD-1 inhibitor, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
433 participants
Where
1 siteChina
Study dates
21 Jul 2021to 21 Oct 2027
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
  • Patients with expected survival time more than 6 months
  • Patients after standard D2/R0 resection
  • Postoperative histologically confirmed adenocarcinoma of the stomach or GEJ
  • Positive lymph nodes more than 7, stage pN3
  • Patients without distant metastasis (M0) or M1 with abdominal exfoliated cell detection positive (CY1P0)
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  • Patients' physical condition and visceral function allows following adjuvant therapy, including chemotherapy, chemoradiotherapy and PD-1 inhibitor therapy.
  • Patients' blood routine and biochemical indicators should meet the following standard: Hb≥90g/L, ANC≥1.5*10^9/L, PLT≥100*10^9/L, ALT \& AST≤2.5 U/L, TB ≤ 1.5 UNL, serum creatinine<1 UNL.
  • Patients who are willing to obey regimens during the study.
  • Written informed consent is acquired before random entry, and patients should know that he/she has the right to quit, and following treatment won't be affected.
  • Patients are willing to provide samples of blood and tissue.

Who cannot join

  • Patients with gross peritoneal metastasis (CY1P0 excluded) or distant metastasis.
  • Patients who has received any anti-tumor therapy before surgery.
  • Patients who had received radiotherapy for abdominal organs including stomach, liver, kidney, etc.
  • Patients who had active systematic autoimmune diseases which need systematic treatment within 2 years before first medication in the study, substitutive therapy (such as thyroxine, insulin, etc) excluded.
  • Patients diagnosed with immunodeficiency, or was receiving systematic glucocorticoid treatment or other immunosuppressive therapy within 7 days before medication, physiological dose of glucocorticoid is allowed (≤10 mg/d prednison or equivalent medication)
  • Patients who have known severe allergic reaction (≥level 3) to anti-PD-1 monoclonal antibody, 5-FU, Oxaliplatin or any auxiliary material.
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  • Patient diagnosed with other malignant tumor in the past 5 years, excluding radical basal cell carcinoma of the skin and/or radical resected carcinoma in situ.
  • Patient with severe vital organ failure.
  • Pregnant or lactation period
  • Patient with known mental illness or drug abuse that may influence compliance.
  • Patient with known HIV infection, or active tuberculosis.
  • Untreated active hepatitis B
  • Patient with active HCV infection
  • Uncontrolled complications
  • Other situations that might disturb study results and compliance.

Trial locations and contacts

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

Zhen Zhang, MD, PhD contact

18801735029

zhen_zhang@fudan.edu.cn

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhen Zhang, MD, PhD, 18801735029, zhen_zhang@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Controlled Phase III Study of Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy as Adjuvant Regimen for D2/R0 Resected pN3 Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma

The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. PD-1+CRT cohort: A total of 216 patients will receive 6 weeks of PD-1 inhibitors and chemotherapy, then receive concurrent chemoradiotherapy, followed by 6 weeks of PD-1 inhibitors and chemotherapy, finally receive maintenance treatment of PD-1 inhibitors until (maximum 1year after radiotherapy). CT cohort: A total of 217 patients will receive 6 months of chemotherapy. The disease-free survival(DFS), overall survival(OS) and adverse effects will be analyzed.

Conditions
Gastric Cancer
Being tested
PD-1 inhibitor, Oxaliplatin, Capecitabine, Tegafur-gimeracil-oteracil potassium, 5-FU
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • PD-1 inhibitorDrug

    Nivolumab/Toripalimab 240mg solution intravenously once daily, Q2W. OR Nivolumab/Toripalimab 360mg solution intravenously once daily, Q3W; OR Pembrolizumab/Tilelizumab/Sintilimab/Carrelizumab, 200mg solution intravenously once daily, Q3W.

  • OxaliplatinDrug

    CapeOx: 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off.

    FOLFOX: 85 mg/m2 (body surface area) solution intravenously once-daily, followed by 13 days off.

  • CapecitabineDrug

    CapeOx: 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

  • Tegafur-gimeracil-oteracil potassiumDrug

    SOX: 40 - 60 mg bid orally in 14 days, followed by 7 days off

  • 5-FUDrug

    FOLFOX：2400-2800mg/m2/d continuous intravenous pumping for 48h, Q2W

  • RadiotherapyRadiation

    1.8 Gy/Fx, 45-50.4 Gy

  • ChemotherapyDrug

    Capecitabine 625mg/m2 bid orally with radiotherapy; ORegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy

Study groups in NCT04997837
Study groupRoleWhat they receive
PD-1 inhibitor and chemoradiotherapyExperimentalPD-1 inhibitor+CapeOX/SOX/FOLFOX for 6 weeks, followed by chemoradiotherapy; 6 weeks of PD-1 inhibitor and CapeOX/SOX/FOLFOX for 6 weeks after chemoradiotherapy, followed by PD-1 inhibitor, till 12 months after chemoradiotherapy. PD-1 inhibitor Nivolumab/Toripalimab 240mg solution intravenously once daily, Q2W. OR Nivolumab/Toripalimab 360mg solution intravenously once daily, Q3W; OR Pembrolizumab/Tilelizumab/Sintilimab/Carrelizumab, 200mg solution intravenously once daily, Q3W. Chemotherapy: CapeOx or SOX or FOLFOX therapy determined by investigator. Chemoradiotherapy Radiotherapy: 1.8 Gy/fx, 45-50.5Gy Chemotherapy: Capecitabine 625mg/m2 bid orally with radiotherapy; OR Tegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy.
Receives: Drug: PD-1 inhibitor; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tegafur-gimeracil-oteracil potassium; Drug: 5-FU; Radiation: Radiotherapy; Drug: Chemotherapy
ChemotherapyActive comparatorChemotherapy: CapeOx or SOX or FOLFOX therapy determined by investigator. CapeOX: Oxaliplatin 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off. SOX: Oxaliplatin 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off. Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 14 days, followed by 7 days off. FOLFOX: Oxaliplatin 85 mg/m2 (body surface area) solution intravenously once-daily, followed by 13 days off. 5-FU 2400-2800mg/m2/d continuous intravenous pumping for 48h, Q2W.
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tegafur-gimeracil-oteracil potassium; Drug: 5-FU

What is being measured

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

  1. 3-year DFS rate

    Defined as the time from randomization to the date of first documented progression or death from any cause.

    Measured: Up to 3 years

Secondary outcomes (4)

  1. 3-year OS rate

    Defined as the time from randomization to death from any cause.

    Measured: Up to 3 years

  2. 3-year local recurrence free survival rate

    Defined as the time from randomization to the date of first documented recurrence or death from any cause.

    Measured: Up to 3 years

  3. Percentage of participants with treatment-related acute adverse events as assessed by CTCAE v5.0

    Measured: Up to 28 days from last dose

  4. Quality of life as assessed by Quality of Life Scale (range 0-60)

    It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.

    Measured: Through study completion, up to 10 years

Timeline

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

  1. First posted10 Aug 2021
  2. Study start21 Jul 2021
  3. Primary completion21 Jul 2027 (estimated)
  4. Study completion21 Oct 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
433 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04997837
Sponsor's protocol ID
FDRT-2021-63-2366
Status last verified
Aug 2021
First submitted
21 Jul 2021
Last updated
10 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang W, Zhou M, Li G, Zhou C, Wang L, Xia F, Zhang H, Shen L, Wang Y, Wan J, Wang Y, Zhao G, Zhang Z. Adjuvant chemoradiotherapy plus PD-1 inhibitor for pN3 gastric cancer: a randomized, multicenter, Phase III trial. Future Oncol. 2024 Dec;20(40):3389-3396. doi: 10.1080/14796694.2024.2421156. Epub 2024 Nov 15.

    PubMed 39545610

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PD-1 inhibitor, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Fudan University at 1 site 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 11 inclusion and 15 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 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Zhen Zhang, MD, PhD (18801735029, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year DFS rate (time frame: Up to 3 years). 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 NCT04997837, which also lists 1 linked publication.

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 10 Aug 2021.

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