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Stomach NeoplasmsPhase 2NCT04694183

The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer

A Phase 2 study testing Camrelizumab, S-1 and Oxaliplatin in people with Stomach Neoplasms, run by Quan Wang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher postoperative metastasis rate.Studies have shown that patients with good pathological response after preoperative… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
Camrelizumab, S-1 and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
17 Aug 2020to 6 May 2023
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

  • The patient voluntarily participates in the study with full informed consent and signs a written informed consent form.
  • Age 18-75 years old, male or female.
  • HER-2 negative unresectable gastric cancer.
  • Patients with gastric cancer who PD-L1+（CPS≥1）or MSI-H/dMMR, or EBV（+）.
  • Patients were assessed by physicians before enrollment to determine eligibility for conversion therapy.
  • The expected survival time of the patient is≥ 12 weeks.
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  • ECOG 0-1.
  • The patient has good organ function: no blood transfusion or colony-stimulating factor and thrombopoietin have been received in the 14 days before the first study, neutrophil count ≥1.5×109/L, platelet count ≥80×109/ L hemoglobin ≥ 80 g/L, serum creatinine ≤ 1.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT, AST ≤ 2.5 times ULN (without liver metastasis) or ≤ 5 times ULN (such as liver metastasis occurred), albumin ≥30 g/L. Requirements for coagulation function: International normalized ratio (INR) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN. Requirements for electrolytes: the corrected serum calcium, blood potassium, and blood magnesium are within the normal range;
  • Women of childbearing age are required to have a pregnancy test (serum or urine) within 7 days of entry and the results are negative and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last drug is given. For men, it should be surgical sterilization or consent to the use of appropriate methods of contraception during the trial and 8 weeks after the last administration of the experimental drug.

Who cannot join

  • Those who are known to be allergic to the study drug or any of its excipients or have had severe allergic reactions.
  • Patients who have received chemotherapy and monoclonal antibodies within 21 days and those who have received radiotherapy within 14 days.
  • Participated in other clinical trials within 21 days before screening.
  • Other malignant tumors have been diagnosed within 5 years before entering the study, except for skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or intraductal carcinoma in situ of the breast that can be treated locally and cured.
  • There is uncontrollable or symptomatic active central nervous system (CNS) metastasis, which can be manifested as clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and/or progressive growth; imaging Prompt asymptomatic spinal cord compression, except for those who have been evaluated by specialists as stable and do not need treatment for the time being; For those who have received CNS metastasis treatment, imaging examinations during the screening period have shown that they have been stable for ≥4 weeks and have been stopped before the first study administration Except for systemic hormone therapy (prednisone or other curative hormones with a dose> 10 mg/day) for ≥ 4 weeks.
  • Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion.
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  • Poorly controlled tumor-related pain; patients who need analgesic treatment, must receive a stable dose of treatment before participating in the study; should be suitable for palliative radiotherapy (for example, bone metastasis or metastasis that causes nerve damage) before enrollment. If appropriate, consider local treatment of asymptomatic metastatic lesions whose further growth may cause functional defects or intractable pain (for example, epidural metastases not related to spinal cord compression).
  • Peripheral neuropathy or hearing loss ≥ 2 (according to NCI-CTCAE 5.0).
  • Pregnant or (confirmed by blood or urine HCG test) or breastfeeding women or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until after the last trial treatment at least 6 months.
  • Patients with moderate to severe liver and kidney dysfunction.
  • Diabetes that is difficult to control (refers to the large fluctuations in blood glucose under standard insulin treatment and frequent blood glucose monitoring, which affects the life of the patient and frequent hypotension).

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Hospital of Jilin University

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: PD-1 Inhibitor Plus Chemotherapy as Conversion Therapy in Unresectable Gastric Cancer (STARS-GC01): A Single-arm, Single-center, Prospective Clinical Study.

Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher postoperative metastasis rate.Studies have shown that patients with good pathological response after preoperative neoadjuvant therapy (such as tumor regression grade, TRG0 or 1) have a better prognosis.The purpose of this study is to treat patients with advanced gastric cancer who are difficult to perform R0 surgery with chemotherapy combined with immunotherapy. At the same time as the primary cancerous lesions are reduced, the distant metastatic lesions are effectively controlled in order to perform R0 surgery and to improve the survival rate of patients with advanced gastric cancer.

Read the detailed description

The interventions include camrelizumab and chemotherapy selected based on the use of different metastatic sites as conversion therapy.

Keywords
gastric cancer, metastasis, conversion therapy, immune checkpoint inhibitors, camrelizumab
Medical subject headings
Stomach Neoplasms, Neoplasm Metastasis

What participants receive

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

  • CamrelizumabDrug

    Also called SHR-1210

    200mg, intravenous drip administration, d1, every 3 weeks.

  • S-1Drug

    Also called Tegafur Gimeracil Oteracil Potassium Capsule

    Oral, d1-14, every 3 weeks.

  • OxaliplatinDrug

    130mg/m² intravenous drip administration, d1, every 3 weeks(For patients with liver and/or para-aortic lymph node metastasis).

  • PaclitaxelDrug

    Intraperitoneal paclitaxel 20 mg/m² and intravenous paclitaxel 50 mg/m² on days 1 and 8, every 3 weeks(For patients with peritoneal metastasis ).

Study groups in NCT04694183
Study groupRoleWhat they receive
Conversion therapyExperimentalCamrelizumab combined with chemotherapy selected per metastasis site.
Receives: Drug: Camrelizumab; Drug: S-1; Drug: Oxaliplatin; Drug: Paclitaxel

What is being measured

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

  1. R0 resection rate

    Defined as no residue under the microscope after resection

    Measured: Within 1 month of surgery.

Secondary outcomes (5)

  1. Pathologic complete response

    The number of people who have achieved complete pathological remission accounted for the proportion of people who met the plan.

    Measured: Within 1 month of surgery.

  2. Overall survival

    The time from the start of system therapy to the death of any cause.

    Measured: From the start of system therapy to death from any cause.

  3. 2-year survival rate

    Percentage of subjects who are alive without death event at two years.

    Measured: 2 years from the start of system therapy.

  4. Adverse events(all grades）

    Assessed per Common Terminology Criteria for Adverse Events(CTCAE) version 5.0

    Measured: From the start of system therapy to 6 months after surgery.

  5. Serious adverse events(≥grade 3）

    Assessed per Common Terminology Criteria for Adverse Events(CTCAE) version 5.0

    Measured: From the start of system therapy to 6 months after surgery.

Timeline

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

  1. First posted5 Jan 2021
  2. Study start17 Aug 2020
  3. Primary completion6 May 2023
  4. Study completion6 May 2023

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04694183
Sponsor's protocol ID
STARS-GC01
Status last verified
Feb 2024
First submitted
20 Nov 2020
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, S-1 and Oxaliplatin in people with Stomach Neoplasms, run by Quan Wang 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 7 Feb 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: Within 1 month of surgery.). 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 NCT04694183.

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 7 Feb 2024.

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