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Gastroesophageal Junction AdenocarcinomaPhase 2CTSCAPOXSEANCT04263870

Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

A Phase 2 study testing sintilimab in people with Gastroesophageal Junction Adenocarcinoma and Stomach Adenocarcinoma, run by Sichuan University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aims to evaluate the efficacy and safety of Sintilimab plus CAPOX in the conversion therapy for patients with unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
Mar 2020to Oct 2021
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

  • Histologic and/or cytologic diagnosis of unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction.
  • Metastatic lesions are resectable or can be controlled by local ablative procedure.
  • Definition of limited metastatic status:
  • abdominal, retroperitoneallymphnodemetastases only (eg,para-aortic, intra aortic-caval, peripancreatic, or mesenterial lymph nodes).
  • One incurable organ site with or without retroperitoneal lymph node metastases. One incurable organ site metastases according to the following schema： - Localized potentially operable peritoneal carcinomatosis or only cytology- positive (Cy1) peritoneal lavage fluid without macroscopic peritoneal metastasis .
  • liver metastasis, and the number of liver metastasis ≤ 3 those are potentially resetabl.
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  • unilateral or bilateral Krukenberg's tumors in the absence of macroscopic peritoneal carcinomatosis.
  • unilateral or bilateral adrenal metastases
  • Extra-abdominal lymph node metastases such as supraclavicular or cervical lymph node involvement.
  • Tumor HER-2 is negative.
  • Age 18-75, gender unlimited.
  • Survival expectation ≥12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  • Not previously treated with any systemic treatment (including HER2 inhibitors), or who have metastasis 6 months after the end of adjuvant chemotherapy or neoadjuvant chemotherapy. (Note: the use of oxaliplatin in previous adjuvant or neoadjuvant therapy should not exceed 800 mg/m2, and the treatment-related toxicity must be restored to common terminology criteria for adverse events (CTCAE) level 1 of the National Cancer Institute [NCI] before randomization.).
  • According to the recist1.1 standard, there is at least one measurable objective tumor focus. The maximum diameter of spiral CT must be ≥ 1cm, and the maximum diameter of normal CT or MRI must be ≥ 2cm, and it should be carried out within 28 days before enrollment.
  • All eligible patients have adequate organ function. According to the following laboratory test results (no blood transfusion, G-CSF or other medical support treatment within 14 days before the drug administration). The laboratory test results within 1 week before the study drug administration meet the following conditions: (HGB≥90 g/L , PLT ≥75 × 10⁹ /L, WBC ≥ 3.0× 10⁹ /L, ANC ≥1.5× 10⁹ / L, TBI ≤1.5 times UNL, Cr≤1.5 times the UNL, ALT and AST ≤2.5 times UNL（5 times UNL )in case of liver metastasis.
  • Subjects with active hepatitis B or active hepatitis C must receive antiviral treatment for at least 14 days before the administration of the first study drug, and pass the detection of hepatitis B virus (HBV) DNA titer (no more than 500 IU / ml or 2500 copies [CPS] / ml) and hepatitis C virus (HCV) RNA (no more than the detection limit of the detection method), which can be included in the group test, and are willing to continue to receive effective antiviral treatment during the study period.
  • Patients participate voluntarily and sign written informed consent

Who cannot join

  • 1.Severe hepatorenal insufficiency or history of myocardial infarction (within 3 months).
  • 2.5-year history of other malignancies(except skin basal cell carcinoma, cervical carcinoma in situ).
  • 3.Subjects with active or previous autoimmune diseases or risks that may recur(eg：requiring immunosuppressive therapy for organ transplantation). However, subjects with type I diabetes, hypothyroidism requiring hormone replacement therapy only, or skin diseases without systemic treatment (such as vitiligo, psoriasis, or alopecia) were allowed to enter the group.
  • 4.Have had interstitial lung disease or noninfective pneumonia, etc. symptoms of the disease or previous lung history may hinder the assessment or management of lung toxicity related to the study drug.
  • 5.Before the first administration of the study drug and who had a history of active tuberculosis infection more than one year ago were considered suitable for inclusion if they were judged by the investigator to have no evidence of active tuberculosis at present.
  • 6.Severe uncontrolled medical disease or acute infection (fever above 38 ℃ caused by infection).
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  • 7.The combination of serious internal and external diseases, affecting organ function, the researchers think it is not suitable to participate in this clinical trial.
  • 8.Pregnant or lactating women or fertile (men or women with menopause less than 1 year) are unwilling to take contraceptive measures.
  • 9.Patients with a long history of chronic diarrhea or complete intestinal obstruction.
  • 10.Subjects requiring systemic treatment with corticosteroids (> 10 mg / day equivalent of prednisone) or other immunosuppressive drugs within 14 days prior to administration of the study drug. Note: if there is no active autoimmune disease, it is allowed to use inhaled or local steroid hormone, or adrenaline replacement therapy with equivalent dose of prednisone ≤ 10 mg per day. Short term (< 7 days) use of glucocorticoids for prophylactic treatment (e.g. contrast agent allergy) or for treatment of non autoimmune diseases (e.g. delayed type hypersensitivity caused by contact allergens) is allowed.
  • 11.Have interstitial lung disease or noninfective pneumonia, etc. symptoms of the disease or previous lung history may hinder the assessment or management of lung toxicity related to the study drug.
  • 12.Subjects who have received any antibody / drug (such as anti-PD-1, anti-PD- L1, anti-CTLA-4, anti OX-40, anti-CD137, anti Tim-3, anti LAG-3 antibody, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
  • 13.Subjects with a history of hypersensitivity or hypersensitivity to study drug components.
  • 14.unable to take oral medicine.
  • 15.Presence of immunodeficient disease or HIV infection.
  • 16.Patients not suitable for this clinical trial determined by the investigator

Trial locations and contacts

1 site in 1 country.

Qiu Li, M.D. contact

+86-28-85422589

fbqiu9@163.com

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: An Exploratory Study of Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

This study aims to evaluate the efficacy and safety of Sintilimab plus CAPOX in the conversion therapy for patients with unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction

Read the detailed description

In a variety of solid tumors such as colorectal cancer, it has been confirmed that some selected advanced patients still have a chance to cure through multidisciplinary treatment. Because of the poor biological behavior of gastric cancer, few people with advanced gastric cancer can benefit from local treatment, and there are fewer related studies. However, retrospective and small sample size prospective phase II clinical studies have also shown that unresectable locally advanced and some selected limited distant metastatic gastric and gastric junction adenocarcinoma patients may also achieve long-term survival through multimodal treatment strategies. The triple drug regimens were often used as conversion regimens in previous studies. Although the efficiency was improved, the R0 resection rate was only about 60%, the disease-free survival was about 10 months, and the toxicity was high. In order to improve the survival of these patients, more effective and less toxic treatment regimens are urgently needed. Objective response rate was 76.5% with anti-PD-1 antibody nivolumab plus CapeOX. The investigators predict that this regimen will achieve good results in the conversion treatment of advanced gastric cancer. The investigators intend to carry out this study to evaluate the efficacy and safety of Sintilimab plus CAPOX in the conversion therapy for patients with unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction. The primary objectives are 12-month progression- free survival (PFS) rate. Secondary objectives include safety, objective response rate (ORR), R0 resection rate , tumor regression grading（TRG）, progression- free survival (PFS) ，overall survival (OS) and exploratory biomarker assessment. Subjects enrolled are treated with oral capecitabine 1000mg per m2 bid for two weeks（every 3 weeks）and intravenous oxaliplatin 130mg per m2（every 3 weeks）in combination with sintilimab 200mg (every 3 weeks) for 3 cycles. After 3 cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD. Patients with SD,PR,CR will be treated with surgery. 36 patients will be included in this study

Being tested
sintilimab
Keywords
adenocarcinoma of the stomach or esophagogastric junction, conversion therapy, Sintilimab, CAPOX, unresectable locally advanced, limited metastasis
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • sintilimabDrug

    Also called capecitabine, oxaliplatin

    oral capecitabine 1000mg per m2 bid d1-14, intravenous oxaliplatin 130mg d1 per m2, sintilimab 200mg (every 3 weeks)

Study groups in NCT04263870
Study groupRoleWhat they receive
Sintilimab plus capecitabine and oxaliplatinExperimentalSubjects enrolled are treated with oral capecitabine 1000mg per m2 bid for two weeks（every 3 weeks）and intravenous oxaliplatin 130mg per m2（every 3 weeks）in combination with sintilimab 200mg (every 3 weeks)
Receives: Drug: sintilimab

What is being measured

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

  1. 12-month Progression Free Survival rate

    Proportion of patients with Progression Free Survival in 12-month

    Measured: Up to 12 months

Secondary outcomes (6)

  1. Objective Response Rate

    Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients

    Measured: Up to 12 months

  2. R0 resection rate

    Proportion of patients with complete resection

    Measured: Up to 12 months

  3. Tumor Regression Grading

    Assessing the grade of tumor regression according to tumor regression grading criteria

    Measured: Up to 12 months

  4. Progression Free Survival

    Defined as the time from the date of enrollment to the first date of documented objective progression disease (defined by RECIST 1.1) or of death from any cause

    Measured: Up to 12 months

  5. Overall Survival

    Defined as the time from the date of enrollment to the date of death from any cause

    Measured: Up to 12 months

  6. Incidence of Treatment-Emergent Adverse Event

    Any adverse events related with treatment with Sintilimab plus CAPOX

    Measured: Up to 12 months

Timeline

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

  1. First posted11 Feb 2020
  2. Study startMar 2020 (estimated)
  3. Primary completionMay 2021 (estimated)
  4. Study completionOct 2021 (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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04263870
Sponsor's protocol ID
BZhang
Acronym
CTSCAPOXSEA
Status last verified
Feb 2020
First submitted
6 Feb 2020
Last updated
11 Feb 2020
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 sintilimab in people with Gastroesophageal Junction Adenocarcinoma and Stomach Adenocarcinoma, run by Sichuan 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 18 inclusion and 16 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 Feb 2020. 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 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 Qiu Li, M.D. (+86-28-85422589, fbqiu9@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month Progression Free Survival rate (time frame: Up to 12 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 NCT04263870.

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 Feb 2020.

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