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Gastric Cancer Stage IIPhase 2NCT04119622

Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer

A Phase 2 study testing Toripalimab, oxaliplatin and capecitabine in people with Gastric Cancer Stage II and Gastric Cancer Stage III, run by Aiping Zhou at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gastric cancer (GC) is one of the most common malignancies. According to the global cancer statistics 2018, there were 1,033,701 new cases of gastric cancer per year, ranked the fifth place in new tumors, and 782,685 deaths, ranked the second place in cancer deaths. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Toripalimab, oxaliplatin and capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
8 Oct 2019to Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, siwert type I was excluded.
  • Clinical determined T3/4 N any or T 1/2 N 2/3 referred to AJCC 8, based on CT, gastroscopy, endoscopic ultrasound, gastrointestinal angiography, general ultrasound, or laparoscope if the patient can afford.
  • No prior chemotherapy and/or immunotherapy and/or radiation therapy.
  • Age 18 to 75 years old.
  • ECOG 0 or 1 .
  • Adequate Organ Function Laboratory Values Hb≥90g/L, WBC≥3.5×109 /L, ANC≥1.5×109 /L, Platelets≥100×109 /L Serum creatinine ≤1.0×ULN ALT≤1.5 ×UNL , AST ≤1.5×ULN，ALP≤ 1.5 ×ULN Serum total bilirubin ≤1.5 × ULN
  • Signed Informed consent

Who cannot join

  • Pathology types other than adenocarcinoma, such as squamous cell carcinoma.
  • intra-abdominal dissemination or distant metastasis (M1).
  • Digestive tract obstruction or repeated bleeding which can not be controlled, clinically significant ascites.
  • Those who cannot swallow pills.
  • Cirrhosis caused by any cause.
  • Heart function NYHA > I degree
Show all 31Show fewer
  • Previous myocardial infarction, unstable angina, stroke and uncontrolled arrhythmia.
  • with any contraindications for surgery.
  • Previously received chemotherapy and or radiation therapy.
  • Previously received any anti-PD 1 , anti - PD L1/L2 antibodies, anti-CTLA 4 antibodies and other immunotherapy.
  • Previously received other anti-tumor treatments.
  • History of surgical resection for gastric cancer.
  • Have had other tumors in the past, except for cured skin cancer and cervical cancer in situ.
  • Accompanied by systemic diseases which cannot meet the conditions of chemotherapy.
  • Pregnancy and lactating patients.
  • History of mental diseases.
  • Poor compliance.
  • Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • History of gastrointestinal perforation and/or fistula in the past 6 months; history of intestinal obstruction (including incomplete intestinal obstruction which need for extraintestinal Nutritional); inflammatory bowel disease or extensive bowel resection(Partial colon resection or extensive small Intestinal resection complicated with chronic diarrhea);Crohn's disease; ulcerative colitis or chronic diarrhea.
  • History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia or active pneumonia.
  • Active tuberculosis (TB), undergoing anti-tuberculosis treatment or within 1 year before the first dose
  • has infected Human immunodeficiency virus (HIV1 / 2 antibody positive).
  • Has known active hepatitis B or hepatitis C. Acute or chronic active hepatitis B or hepatitis C virus infection, hepatitis B virus (HBV) DNA > 2000 IU / ml or 10^4 copies / ml; Hepatitis C virus (HCV) RNA > 10^3 copies / ml ; hepatitis B surface antigen(HbsAg) and anti-HCV antibody is positive at the same time.
  • Severe infections active or poorly controlled. Severe infections within 4 weeks before the first dose, includes but not limited to hospitalization attributed to infection, bacteremia or severe pneumonia complications.
  • Active autoimmune disease requiring systemic treatment or the history within 2 years (one with vitiligo, psoriasis, alopecia or Graves' disease not requiring systemic treatment in the last 2 years, hypothyroidism only requiring thyroid hormones alternative treatment and type 1 diabetes only requiring insulin replacement therapy can be enrolled). Have has known history of primary immunodeficiency. patients with positive autoimmune antibodies only will need to be confirmed the presence of autoimmune diseases according to the investigator's judgment.
  • Application of immunosuppressive drugs within the latest 4 weeks, excluding nasal glucocorticoids and topical glucocorticoids by inhaling or other routings. Physiological doses of systemic glucocorticoids (prednisone not exceeding 10 mg/day or equivalent dose of other glucocorticoids) and temporary use of glucocorticoids for the treatment of dyspnea caused by asthma, chronic obstructive pulmonary disease and other diseases would be allowed.
  • have received live attenuated vaccines within 4 weeks or intend to be vaccinated during the study period.
  • have received systemic immunostimulant treatment within 4 weeks.
  • Have undergone major surgery (such as craniotomy, thoracotomy or laparotomy) within 4 weeks, or unhealed wound, ulcer or fracture at present.
  • Have uncontrolled metabolic disorders , other non-malignant tumors, systemic diseases or secondary reactions originated from the cancer which may lead to higher medical risks and/or the uncertainty of survival evaluation.
  • patients with other acute or chronic diseases, psychiatric disorders, or abnormal laboratory tests that may lead to the increasing risk of participating the research and drug administration, or interference results Interpretation, whom may be excluded from the study according to the investigator's judgment.

Trial locations and contacts

2 sites in 1 country.

Aiping Zhou, doctor contact

+86 13691161998

zhouap1825@126.com

China2 sites, 2 recruiting

  • Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Aiping Zhou, MD, +8613691161998 ext. +8613691161998, zhouap1825@126.com

    Recruiting

  • Chinese Academy of Medical Sciences

    Beijing, 10000

    Ai ping Zhou, 8610-87788145, zhouap1825@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study of XELOX and Toripalimab in the Neoadjuvant Treatment of Stage II/III Gastric or GE Junction Adenocarcinoma

Gastric cancer (GC) is one of the most common malignancies. According to the global cancer statistics 2018, there were 1,033,701 new cases of gastric cancer per year, ranked the fifth place in new tumors, and 782,685 deaths, ranked the second place in cancer deaths. At present, surgery is the only way to cure gastric cancer, but the 5-year survival rate is only 20%-30%. studies have confirmed that neoadjuvant therapy could improve the R0 resection rate and overall survival, which is considered a better treatment strategy.

PD 1 monoclonal antibody is definitely effective in neoadjuvant therapy in other tumors such as NSCLC and bladder cancer, especially in PD-L1+ patients. However, there is no research of PD-1 monoclonal antibody in neoadjuvant therapy of gastric cancer. Thus we plan to conduct this prospective phase II clinical trial, evaluating the safety and efficacy of toripalimab, also known as JS001, in combination with XELOX for the neoadjuvant therapy of gastric cancer.

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 study criteria will receive the combination of toripalimab (240 mg d1) with XELOX (oxaliplatin 130 mg/m2 QD, d1, capecitabine 1000 mg/m2 BID, d1-d14) of a 3-week treatment cycle up to two cycles. After the second cycle of treatment, clinical efficacy evaluation will be done by MDT according to iRECIST. For patients with CR/PR/SD, surgery will be performed within 4 weeks. For patients with disease progress, MDT will determine whether the surgery could be performed. If resection could not be done, the patients would receive Original chemotherapy with toripalimab for 1 more cycle, chemoradiotherapy or the second line chemotherapy. The primary endpoint is Major pathological response.

Keywords
Toripalimab, JS001, Gastric Cancer, neoadjvant chemotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • ToripalimabDrug

    toripalimab 240 mg d1; q3w, up to two cycles.

  • oxaliplatinDrug

    oxaliplatin 130 mg/m2 QD, d1,q3w, up to two cycles

  • capecitabineDrug

    apecitabine 1000 mg/m2 BID, d1-d14 ,q3w, up to two cycles

Study groups in NCT04119622
Study groupRoleWhat they receive
XELOX combined with ToripalimabExperimentalNot described
Receives: Drug: Toripalimab; Drug: oxaliplatin; Drug: capecitabine

What is being measured

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

  1. Major pathological response rate

    Proportion of subjects with residual tumor less than 10% or complete response

    Measured: Up to 6 months

Secondary outcomes (5)

  1. Incicende of Adverse Events (AEs)

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

    Measured: Up to 6 months

  2. Pathologic Complete Response (pCR) Rate

    Proportion of subjects with absence of viable tumor on surgical resection specimen as determined by local pathology review.

    Measured: Up to 6 months

  3. Overall Response Rate (ORR)

    Proportion of subjects with initial RECIST 1.1 measurable disease who have complete response (CR) or partial response (PR) according to iRECIST

    Measured: Up to 6 months

  4. Disease Free Survival (DFS)

    Time from Cycle 1 Day 1 treatment administration to the first documented event of: disease progression, disease recurrence following surgery (preferably biopsy proven), or death - whichever occurs first.

    Measured: Up to 5 years

  5. Overall Survival (OS)

    Time from Cycle 1 Day 1 treatment administration to death due to any cause.

    Measured: Up to 5 years

Timeline

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

  1. First posted8 Oct 2019
  2. Study start8 Oct 2019
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completionOct 2024 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04119622
Sponsor's protocol ID
JS001-ISS-CO63
Status last verified
Mar 2022
First submitted
7 Oct 2019
Last updated
11 Mar 2022
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, oxaliplatin and capecitabine in people with Gastric Cancer Stage II and Gastric Cancer Stage III, run by Aiping Zhou 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 7 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. 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?

Results are not available in the source record.

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

Contact Aiping Zhou, doctor (+86 13691161998, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological 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 NCT04119622.

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 11 Mar 2022.

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