Conversion Effects of PD-1 Antibody Camrelizumab Combined With Nab-POF Regimen Chemotherpy in Patients With Initially Unresectable Locally Advanced or Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma：FDZL-GC001 Trial

NCT04510064 | Completed Phase 2

• 1 other identifier: FDZL-PFG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy and safety of domestic programmed death 1（ PD-1） antibody (Camrelizumab for injection) combined with fluorouracil plus leucovorin, oxaliplatin, and albumin bound paclitaxel (Nab-POF) regimen in the treatment of patients with unresectable locally advanced or limited metastatic gastric cancer. The primary efficacy endpoint is R0 resection rate.

Conditions

Metastatic Gastric Cancer; Locally Advanced Gastric Adenocarcinoma; Gastric Cancer Adenocarcinoma Metastatic

Keywords

gastric cancer; gastroesophageal adenocarcnoma; conversion chemotherapy; PD-1antibody

Outcome Measures

Primary Outcomes (1)

• margin-free-(R0) resection rate

  R0 resection was defined as no tumor identified on microscopic examination of proximal, distal,or circumferential margins.

  6-9 weeks after immunochemotherapy

Secondary Outcomes (6)

• pathological complete response (pCR)

  6-9 weeks after immunochemotherapy and R0 surgery

• overall response rate (ORR)

  up to 24 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  up to 24 months

• sugery complications

  up to 2 months after the period of surgery

• progression free survival (PFS)

  up to 24 months

Study Arms (1)

Treatment group

EXPERIMENTAL

Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every two weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity.

Drug: Camrelizumab plus mFLOT regimen; Procedure: R0 surgery

Interventions

Camrelizumab plus mFLOT regimen DRUG

Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every three weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.

Treatment group

R0 surgery PROCEDURE

The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity.

Treatment group

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained.
• Age ≥ 18 years at time of study entry, no gender limit.
• Participants must have histologically or cytologically confirmed adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction).
• At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.
• CT or MRI showed unresectable locally advanced gastric cancer (imaging stage T4b and / or second station lymph node \> 3cm or fusion mass) or limited metastatic gastric cancer with any of the following single site metastasis:
• Retro-peritoneal lymph node metastasis (RPLM) (e.g. para-aortic, intra-aorto-caval, para-pancreatic or mesenteric lymph nodes).
• Single or bilateral Krukenberg tumors.
• No more than 5 liver metastases, and the maximum diameter of the lesions was less than 5 cm.
• Adrenal metastasis.
• Localized potentially operable peritoneal carcinomatosis: stage P1 according to classification of the"Japanese Research Society for Gastric Cancer (JRSCGC)".
• No clinically visible peritoneal metastasis (such as CT imaging confirmation or ascites).
• No prior anti-tumor therapy.
• Performance status (PS) \< 2 (ECOG scale).
• Life expectancy of at least 12 weeks.
• Adequate blood count, liver-enzymes, and renal function: hemoglobin≥90g/dL,absolute neutrophil count ≥ 1.5×109/L, platelets ≥100 x109/L; Total bilirubin \< 1.5x upper normal limit (UNL), Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) \<2.5 x ULN, if liver metastasis existed, SGOT,SGPT\<2.5xULN. International normalized ratio (INR) ≤2.5 x ULN, Serum Creatinine ≤ 1 x institutional ULN or creatinine clearance (CrCl) \>50ml/min (if using the Cockcroft-Gault formula ).

You may not qualify if:

• A history of other malignancies within 3 years prior to enrollment, except for cervical carcinoma in situ or skin basal cell carcinoma that had been cured.
• Accompanied with brain or meningeal metastasis.
• Malignant pleural and peritoneal effusion.
• Accompanied by gastrointestinal obstruction, gastrointestinal bleeding (fecal occult blood +++ )or perforation.
• Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137,or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
• Has an active or history of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or with high risk (such as receiving immunosuppressive therapy after organ transplantation), but in the past two years with vitiligo, psoriasis, alopecia or Graves' disease without systemic treatment, hypothyroidism with thyroid hormone replacement therapy only and type I diabetes only need insulin replacement therapy can be enrolled.
• Suffering from interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease and radiation pneumonia.
• Participate in other clinical studies of drugs (subject to the use of trial drugs) within 4 weeks before the first administration, unless participating in observational (non intervention) clinical studies.
• Used immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding nasal, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (i.e. no more than 10mg prednisone or equivalent dose of other glucocorticoids, or short-term (no more than 7 days) use of glucocorticoids to prevent or treat non autoimmune allergic diseases.
• Planned to receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period. Note: inactivated virus vaccine for seasonal influenza is allowed within 4 weeks before the first administration, however, live attenuated influenza vaccine is not allowed.
• Major surgery (craniotomy, thoracotomy or laparotomy) was performed within 4 weeks before the first dose of study treatment, or major surgery (not in this study) was expected to be performed during the study treatment.
• A history of HIV infection (i.e. HIV antibody positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or stem cell transplantation.
• Patients with active chronic hepatitis B or active hepatitis C, hepatitis B virus carriers. Stable hepatitis B after drug treatment (DNA titer not higher than 200iu/ml or copy number \< 1000copies / ml) and cured patients with hepatitis C (HCV RNA test negative) can be included in the group.
• Active tuberculosis.
• Severe infection within 4 weeks before the first administration, or active infection within the first 2 weeks and requiring oral or intravenous antibiotic treatment.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University, Shanghai Cancer Center

Shanghai, Shanghai Municipality, 210000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• weijian guo, professor

  Fudan university, Shanghai Cancer Certer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen, and HER-2 positive patients were added Herceptin therapy. If primary tumor and metastatic lesions could be converted to R0 resection after 6-9 cycles of immunochemotherapy, then proceeded to surgery,otherwize treated according to the principles of palliative care. Patiens after surgery continued prior immunotherapy to 12 cycles or intolerable toxicity.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: January 6, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CN (1)