Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

NCT07320586 | Recruiting Phase 2

• 1 other identifier: MA-GC-II-010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study was an open, single center, prospective cohort study design. Subjects with advanced gastric cancer who had received first-line chemotherapy (cohort 1) and systematic chemotherapy combined with immunotherapy (cohort 2) were included in this study. 20 cases were included in each population, and a total of 40 subjects were planned to be included.

Conditions

Gastric Cancer; Second-line Therapy

Keywords

Immune checkpoint inhibitors；; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• mPFS

  median Progression free survival

  [Time Frame: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years]

Secondary Outcomes (3)

• mOS

  [Time Frame: The longest follow-up period from the patient's enrollment to death from any cause is 2 years]

• DCR

  [Time Frame: The longest follow-up period from enrollment to the first efficacy evaluation is 3 months]

• safety：Record the incidence rate of all adverse events

  [Time Frame: From enrollment until 90 days after the last dose of medication]

Study Arms (2)

Group 1

EXPERIMENTAL

Subjects with advanced gastric cancer who have been included in first-line treatment and have received systemic chemotherapy in the past. Administration method: Camrelizumab 200mg, d1, q3w, Albumin bound paclitaxel 100mg/m2 on days 1 and 8, q3w， Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of administration for Camrelizumab is 2 years, while the longest duration of treatment for albumin bound paclitaxel is 6-8 cycles.

Drug: Camrelizumab; Drug: Nab paclitaxel

Group 2

EXPERIMENTAL

Advanced gastric cancer subjects included in the first-line treatment progression, who have previously received systemic chemotherapy combined with immunotherapy in the first-line treatment Administration method: Camrelizumab 200mg, d1, q3w, Albumin bound paclitaxel 100mg/m2 on days 1 and 8, q3w， Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of administration for Camrelizumab is 2 years, while the longest duration of treatment for albumin bound paclitaxel is 6-8 cycles.

Drug: Camrelizumab; Drug: Nab paclitaxel

Interventions

Camrelizumab DRUG

Camrelizumab 200mg，d1，q3w.Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of use for Carilizumab is 2 years

Group 1; Group 2

Nab paclitaxel DRUG

nab-paclitaxel 100mg/m2 D1、8，q3w， Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest treatment time for albumin bound paclitaxel is 6-8 cycles.

Also known as: nab-paclitaxel

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Age range: 18 to 75 years old, both male and female are acceptable;
• Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
• Gastric cancer patients who have previously received first-line systemic chemotherapy (queue 1) or systemic chemotherapy combined with immunotherapy (queue 2) for progression; For intervention group 2, the best response to first-line immunotherapy is CR or PR or SD ≥ 3 months;
• According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);
• ECOG score: 0-1 point;
• Expected survival period ≥ 12 weeks;
• The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula);
• Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period, at least 6 months after the last use of Carilizumab, and at least 6 months after the last use of chemotherapy;
• HER2 negative;
• Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

You may not qualify if:

• History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
• There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
• History of allergies to monoclonal antibodies, any component of Carilizumab, or albumin bound paclitaxel;
• Have received any of the following treatments:
• Patients who have experienced serious adverse reactions to immunotherapy in the past and are deemed unsuitable for continued use of immunotherapy by the researchers;
• Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;
• Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;
• Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;
• Subjects who need to receive corticosteroids (equivalent to\>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones;
• Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug;
• Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;
• Patients who have received previous treatment with paclitaxel drugs;
• Patients with central nervous system metastases;
• Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding childhood asthma/allergies with vitiligo or those who have already recovered, patients who do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;
• Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU/ml or 2500 copies/mL);

Sponsors & Collaborators

• Shandong Tumor Hospital: lead

Study Sites (1)

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, 250021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; Taxes; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Zuoxing Niu, Professor

  Shandong First Medical University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zuoxing Niu, Prof.

CONTACT

+86 13506413687; nzxsdth@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: March 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CN (1)