The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer

NCT04694183 | Completed Phase 2

• 1 other identifier: STARS-GC01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stomach Neoplasms

Keywords

gastric cancer; metastasis; conversion therapy; immune checkpoint inhibitors; camrelizumab

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Defined as no residue under the microscope after resection

  Within 1 month of surgery.

Secondary Outcomes (5)

• Pathologic complete response

  Within 1 month of surgery.

• Overall survival

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

• 2-year survival rate

  2 years from the start of system therapy.

• Adverse events(all grades）

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

• Serious adverse events(≥grade 3）

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

Study Arms (1)

Conversion therapy

EXPERIMENTAL

Camrelizumab combined with chemotherapy selected per metastasis site.

Drug: Camrelizumab; Drug: S-1; Drug: Oxaliplatin; Drug: Paclitaxel

Interventions

Camrelizumab DRUG

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

Also known as: SHR-1210

Conversion therapy

S-1 DRUG

Oral, d1-14, every 3 weeks.

Also known as: Tegafur Gimeracil Oteracil Potassium Capsule

Conversion therapy

Oxaliplatin DRUG

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

Conversion therapy

Paclitaxel DRUG

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

Conversion therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Quan Wang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

camrelizumab; S 1 (combination); Oxaliplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Quan Quan, MD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: January 5, 2021
• Study Start: August 17, 2020
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)