Efficacy and Safety of Sintilimab Combined With Nab-paclitaxel and Tegio (aTS) as First-line Treatment of Unresectable Locally Advanced, Recurrent or Metastatic Adenocarcinoma of Gastric and Gastroesophageal Junction，a Phase II Clinical Study

NCT06241469 | Not Yet Recruiting Phase 2

• 1 other identifier: CMCC201312
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find better protocal for adenocarcinoma of the gastric and gastroesophageal juncion. The main question is aim to answer is: 1\. The efficacy and safety of PD-1 monoclonal antibody (Sintilimab) combined with nab-paclitaxel and S-1 in the first-line treatment of advanced gastric and gastroesophageal junction adenocarcinoma. Participants will be given PD-1 monoclonal antibody, nab-paclitaxel and tegio.

Conditions

Gastric Cancer; GastroEsophageal Cancer; Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS)

  Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

  from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

• Objective response rate (ORR)

  Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

  from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

Secondary Outcomes (3)

• Overall survival (OS)

  from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

• Disease control rate (DCR)

  from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

• Disease control rate (DOR)

  from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Sintilimab combined with nab-paclitaxel and tegio

Drug: Sintilimab,nab-paclitaxel and tegio

Interventions

Sintilimab,nab-paclitaxel and tegio DRUG

Immunotherapy combined with chemotherapy

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non resectable locally advanced, recurrent, or metastatic adenocarcinoma at the junction of the stomach and esophagus (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) confirmed by histopathological examination.
• Age ≥ 18 years old.
• The ECOG PS score is 0 or 1.
• The time from the end of previous (new) adjuvant chemotherapy/radiotherapy to disease recurrence is greater than 6 months.
• Palliative treatment for local lesions (non target lesions) should last for more than 2 weeks until randomization.
• According to RECIST v1.1, there should be at least one measurable or evaluable lesion.
• Can provide archived or fresh pathological tissues within 6 months from the signing of the informed consent document for PD-L1 testing and obtain test results.
• Having sufficient organ and bone marrow functions, defined as follows:
• \) Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT)≥ 100 × 109/L; Hemoglobin content (HGB) ≥ 8.0 g/dL. No G-CSF, GM-CSF, Meg CSF, TPO, EPO, red blood cell transfusions or platelet transfusions were not used within the first 7 days of the examination.
• \) Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) ≤ 1.5 × Normal upper limit (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. Patients with liver metastasis require serum total bilirubin (TBIL) ≤ 1.5 × Normal upper limit (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN.
• \) Renal function: Glomerular filtration rate (GFR) ≥ 60 mL/min(Calculate using the CKD-EPI formula) 4) Adequate coagulation function is defined as an international standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN; If the subject is receiving anticoagulant treatment, as long as the PT is within the range of anticoagulant drugs prescribed; 5) Urinary routine: Urinary protein\<2+; If the urine protein is ≥ 2+, the 24-hour urine protein quantification needs to be\<1.0 g.
• \. Expected survival time ≥ 24 weeks. 10. Female participants of childbearing age or male participants whose sexual partners are female participants of childbearing age are required to take effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.
• \. Sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan.

You may not qualify if:

• Known signs of active bleeding in the lesion (excluding positive fecal occult blood).
• Obstruction of the cardia and pylorus can affect the patient's eating and gastric emptying, or hinder the swallowing of medication.
• Diagnosed as HER2 positive adenocarcinoma at the junction of the stomach and esophagus.
• Previously received systematic treatment for advanced or metastatic adenocarcinoma at the junction of the stomach and esophagus.
• Peripheral neurotoxicity has not recovered to level 1 after previous treatment.
• It is known that dihydropyrimidine dehydrogenase (DPD) is deficient (or has experienced mucosal toxicity of grade 3 or higher in previous fluorouracil containing treatments).
• Known to be allergic to any monoclonal antibody or chemotherapy drug (tigio, albumin bound paclitaxel) formulation component (having experienced grade 3 or above allergic reactions).
• Previously exposed to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug targeting T cell co stimulation or checkpoint pathways.
• Participate in another intervention clinical study at the same time, unless participating in an observational (non intervention) clinical study or in the follow-up stage of an intervention study.
• Within 2 weeks before the first administration, systemic systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor indications has been received;
• Within 4 weeks prior to the first dose of study treatment, immunosuppressive drugs were used, excluding local corticosteroids administered through nasal spray, inhalation, or other routes, or systemic corticosteroids administered at physiological doses (i.e. no more than 10 mg/day of prednisone or equivalent doses of other corticosteroids), or steroids were used to prevent contrast agent allergies.
• Within 4 weeks prior to the first dose of study treatment or planned to receive attenuated live vaccines during the study period.
• Note: It is allowed to receive inactivated viral vaccines for seasonal influenza within 4 weeks before the first administration; But it is not allowed to receive attenuated live influenza vaccines;
• Have undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or are expected to require major surgery during the study treatment period; Laparoscopic exploration surgery was performed within 2 weeks prior to the first dose of study treatment.
• Toxicity (excluding hair loss, non clinically significant, and asymptomatic laboratory abnormalities) at level 0 or 1 of the National Cancer Institute Common Standard Terminology 5.0 (NCI CTCAE v5.0) caused by previous anti-tumor treatments prior to the initial study treatment.

Sponsors & Collaborators

• Wu Jun: lead

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213004, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Jian Ma, PhD

CONTACT

+8615951208100; azskyhorse@outlook.com

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: Professor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: February 3, 2024
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): February 2, 2027
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

CN (1)