Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

NCT04263870 | Unknown Phase 2

• 1 other identifier: BZhang
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of Sintilimab plus CAPOX in the conversion therapy for patients with unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction

Conditions

Gastroesophageal Junction Adenocarcinoma; Stomach Adenocarcinoma; Locally Advanced Unresectable Gastric Adenocarcinoma; Metastatic Gastric Cancer

Keywords

adenocarcinoma of the stomach or esophagogastric junction; conversion therapy; Sintilimab; CAPOX; unresectable locally advanced; limited metastasis

Outcome Measures

Primary Outcomes (1)

• 12-month Progression Free Survival rate

  Proportion of patients with Progression Free Survival in 12-month

  Up to 12 months

Secondary Outcomes (6)

• Objective Response Rate

  Up to 12 months

• R0 resection rate

  Up to 12 months

• Tumor Regression Grading

  Up to 12 months

• Progression Free Survival

  Up to 12 months

• Overall Survival

  Up to 12 months

Study Arms (1)

Sintilimab plus capecitabine and oxaliplatin

EXPERIMENTAL

Subjects enrolled are treated with oral capecitabine 1000mg per m2 bid for two weeks（every 3 weeks）and intravenous oxaliplatin 130mg per m2（every 3 weeks）in combination with sintilimab 200mg (every 3 weeks)

Drug: sintilimab

Interventions

sintilimab DRUG

oral capecitabine 1000mg per m2 bid d1-14, intravenous oxaliplatin 130mg d1 per m2, sintilimab 200mg (every 3 weeks)

Also known as: capecitabine, oxaliplatin

Sintilimab plus capecitabine and oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Histologic and/or cytologic diagnosis of unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction.
• Metastatic lesions are resectable or can be controlled by local ablative procedure.
• Definition of limited metastatic status:
• abdominal, retroperitoneallymphnodemetastases only (eg,para-aortic, intra aortic-caval, peripancreatic, or mesenterial lymph nodes).
• One incurable organ site with or without retroperitoneal lymph node metastases. One incurable organ site metastases according to the following schema： - Localized potentially operable peritoneal carcinomatosis or only cytology- positive (Cy1) peritoneal lavage fluid without macroscopic peritoneal metastasis .
• liver metastasis, and the number of liver metastasis ≤ 3 those are potentially resetabl.
• unilateral or bilateral Krukenberg's tumors in the absence of macroscopic peritoneal carcinomatosis.
• unilateral or bilateral adrenal metastases
• Extra-abdominal lymph node metastases such as supraclavicular or cervical lymph node involvement.
• Tumor HER-2 is negative.
• Age 18-75, gender unlimited.
• Survival expectation ≥12 weeks.
• Eastern Cooperative Oncology Group (ECOG) 0 or 1.
• Not previously treated with any systemic treatment (including HER2 inhibitors), or who have metastasis 6 months after the end of adjuvant chemotherapy or neoadjuvant chemotherapy. (Note: the use of oxaliplatin in previous adjuvant or neoadjuvant therapy should not exceed 800 mg/m2, and the treatment-related toxicity must be restored to common terminology criteria for adverse events (CTCAE) level 1 of the National Cancer Institute \[NCI\] before randomization.).
• According to the recist1.1 standard, there is at least one measurable objective tumor focus. The maximum diameter of spiral CT must be ≥ 1cm, and the maximum diameter of normal CT or MRI must be ≥ 2cm, and it should be carried out within 28 days before enrollment.

You may not qualify if:

• Severe hepatorenal insufficiency or history of myocardial infarction (within 3 months).
• year history of other malignancies(except skin basal cell carcinoma, cervical carcinoma in situ).
• Subjects with active or previous autoimmune diseases or risks that may recur(eg：requiring immunosuppressive therapy for organ transplantation). However, subjects with type I diabetes, hypothyroidism requiring hormone replacement therapy only, or skin diseases without systemic treatment (such as vitiligo, psoriasis, or alopecia) were allowed to enter the group.
• Have had interstitial lung disease or noninfective pneumonia, etc. symptoms of the disease or previous lung history may hinder the assessment or management of lung toxicity related to the study drug.
• Severe uncontrolled medical disease or acute infection (fever above 38 ℃ caused by infection).
• The combination of serious internal and external diseases, affecting organ function, the researchers think it is not suitable to participate in this clinical trial.
• Pregnant or lactating women or fertile (men or women with menopause less than 1 year) are unwilling to take contraceptive measures.
• Patients with a long history of chronic diarrhea or complete intestinal obstruction.
• Subjects requiring systemic treatment with corticosteroids (\> 10 mg / day equivalent of prednisone) or other immunosuppressive drugs within 14 days prior to administration of the study drug. Note: if there is no active autoimmune disease, it is allowed to use inhaled or local steroid hormone, or adrenaline replacement therapy with equivalent dose of prednisone ≤ 10 mg per day. Short term (\< 7 days) use of glucocorticoids for prophylactic treatment (e.g. contrast agent allergy) or for treatment of non autoimmune diseases (e.g. delayed type hypersensitivity caused by contact allergens) is allowed.
• Have interstitial lung disease or noninfective pneumonia, etc. symptoms of the disease or previous lung history may hinder the assessment or management of lung toxicity related to the study drug.
• Subjects who have received any antibody / drug (such as anti-PD-1, anti-PD- L1, anti-CTLA-4, anti OX-40, anti-CD137, anti Tim-3, anti LAG-3 antibody, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
• Subjects with a history of hypersensitivity or hypersensitivity to study drug components.
• unable to take oral medicine.
• Presence of immunodeficient disease or HIV infection.
• Patients not suitable for this clinical trial determined by the investigator

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Qiu Li, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiu Li, M.D.

CONTACT

+86-28-85422589; fbqiu9@163.com

Study Design

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

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 11, 2020
• Study Start: March 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

CN (1)