Official Title
An Exploratory Study of Immunotherapy Combined With Anlotinib Hydrochloride Capsules and Chemotherapy in Perioperative Treatment of Locally Advanced Novel Coronavirus Infected Gastric Cancer
Brief Summary

- 1. Main objective: to evaluate the pathological complete response (pCR) of gastric cancer after local advanced COVID-19 infection by two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy. - 2. Secondary objective: to evaluate the major pathological response (MPR), disease-free survival (DFS), objective response rate (ORR), R0 resection rate (R0 resection rate) and safety of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy for gastric cancer after local advanced COVID-19 infection。

Detailed Description

This is a prospective multicenter exploratory study to evaluate the efficacy and safety
of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and
chemotherapy for resectable or potentially resectable T3~4N+M0 locally advanced gastric
cancer after COVID-19 infection This study was led by Professor Hongliu, Department of
Gastroenterology, Xijing Hospital. 114 patients with resectable or potentially resectable
T3~4N+M0 locally advanced gastric cancer were planned to be randomly divided into two
groups: one group received peri-operative treatment with Penpulimab combined with
Anlotinib Hydrochloride Capsules and chemotherapy, and the other group received
peri-operative treatment with Cadonilimab combined with Anlotinib Hydrochloride Capsules
and chemotherapy. Each subject will receive three cycles of neoadjuvant study treatment:
Pianzumab (single immunity, fixed dose 200mg) or Cadonilimab (double immunity, fixed dose
500mg), which will be administered on the first day of each cycle and repeated every
three weeks; Anlotinib Hydrochloride Capsules: 12mg, administered on the 1-14th day of
each cycle, once a day, about half an hour before breakfast (the time of daily
administration should be the same as much as possible), delivered with warm water,
repeated once every 3 weeks; Tegafur: It needs to be administered according to the
patient's body surface area< 40 mg/time at 1.25 m2; ≥ 50 mg/time when 1.25m2 and<1.5 m2;
≥ 60 mg/time at 1.5 m2; Take orally, twice a day, after breakfast and dinner, for 14
consecutive days, and rest for 7 days, which is a treatment cycle; Repeat once every 3
weeks; Oxaliplatin: 130 mg/m2, administered on the first day of each cycle, repeated
every three weeks.

Unknown status
Gastric Cancer

Drug: Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy

one group receives peri operative treatment of Penpulimab combined with Anlotinib
Hydrochloride Capsules and chemotherapy, and the other group receives peri operative
treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and
chemotherapy.After receiving corresponding neoadjuvant treatment for 3 cycles according
to the established treatment plan, surgical treatment shall be carried out within 3-6
weeks after drug withdrawal
Other Name: Teggio,Oxaliplatin

Eligibility Criteria

Inclusion Criteria:

- 18 years old ≤ age ≤ 70 years old, male or female;

- ECOG score 0-1 points;

- Patients with locally advanced gastric cancer confirmed by pathology (histology or
cytology) (according to WHO classification in 2015);

- Nucleic acid test or antigen test to identify patients with COVID-19 infection

- According to the TNM stage of clinical tumor in the 8th edition, T3~4N+M0 gastric
cancer patients confirmed as resectable or potentially resectable by endoscopic
ultrasound and enhanced CT;

- It has measurable lesions (according to RECIST 1.1 standard, the long diameter of CT
scan of tumor lesions is ≥ 10mm, and the short diameter of CT scan of lymph node
lesions is ≥ 15mm;);

- Those who were diagnosed as gastric cancer for the first time before enrollment and
did not undergo radiotherapy, chemotherapy, surgery and targeted treatment;

- The function of main organs is normal, that is, they meet the following standards:

- The blood routine examination must meet the following requirements (no blood
transfusion, no hemopoietic factor and no drug correction within 14 days):

- ANC ≥ 1.5 × 109/L;

- PLT ≥ 100 × 109/L;

- HB ≥ 90 g/L;

- Biochemical examination shall meet the following standards:

- TBIL≤1.5 × ULN;

- ALT、AST≤ 2.5 × ULN

- Serum creatinine sCr ≤ 1.5 × ULN, endogenous creatinine clearance ≥ 50 mL/min
(Cockcroft-Gault formula);

- Coagulation function must meet: INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN;

- Female subjects of childbearing age must carry out a serum pregnancy test within 3
days before starting the study medication, and the result is negative, and are
willing to use a medically approved effective contraceptive measure (such as
intrauterine device, contraceptive or condom) during the study period and within 3
months after the last administration of the study medication; For male subjects
whose partners are women of childbearing age, they should undergo surgical
sterilization or agree to use effective methods of contraception during the study
and within 3 months after the last study administration;

- Subjects voluntarily joined the study and signed the informed consent form, with
good compliance and cooperation in follow-up;

Exclusion criteria:

- Patients with distant metastasis;

- Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibodies;

- Medical history and complications

- Other malignant tumors in the past 3 years;

- Have any history of active autoimmune diseases or autoimmune diseases (including but
not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis,
vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included
after hormone replacement therapy); Patients with vitiligo or childhood asthma have
been completely relieved and can be included without any intervention after
adulthood; Patients who need bronchodilator for medical intervention cannot be
included;

- Immunosuppressive drugs were used within 14 days before the first use of the study
drug, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones
with physiological dose (i.e. no more than 10 mg/day prednisone or its equivalent);

- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood
pressure ≥ 90 mmHg, despite the best drug treatment);

- Newly diagnosed angina pectoris within 3 months before screening or myocardial
infarction events within 6 months before screening; Arrhythmias (including QTcF:
male ≥ 450 ms, female ≥ 470 ms) require long-term use of antiarrhythmic drugs and
cardiac insufficiency of New York Heart Association grade ≥ II; Or uncontrolled
heart failure;

- There is evidence that there is pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiological pneumonia, drug-induced pneumonia and serious damage to
lung function in the past or at present;

- Severe infection (such as the need for intravenous drip of antibiotics, antifungal
or antiviral drugs) occurred within 4 weeks before the first administration, or
fever of unknown cause occurred during screening/before the first
administration>38.5 ° C;

- There is clinically significant hemoptysis (more than 50 mL of hemoptysis per day)
within the first three months of the study, or there is clinically obvious bleeding
symptom or obvious bleeding tendency (such as gastrointestinal bleeding, gastric
ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult
blood++or above the baseline, or suffering from vasculitis).

- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation;

- Inoculate live attenuated vaccine within 4 weeks before the first administration or
during the study period;

- Physical examination and laboratory examination findings

- People with congenital or acquired immune deficiency, such as people infected with
human immunodeficiency virus (HIV), active hepatitis B (HBV DNA ≥ 500 IU/mL),
hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection
limit of the analytical method) or combined with hepatitis B and hepatitis C
infection;

- Pregnant or lactating women; Those with fertility who are unwilling or unable to
take effective contraceptive measures;

- Known to have a positive history of human immunodeficiency virus (HIV) test or known
to have acquired immunodeficiency syndrome (AIDS);

- Allergic reactions, allergic reactions and adverse drug reactions

- Severe allergic reaction to other monoclonal antibodies;

- Allergy or intolerance to infusion;

- Have a history of severe allergy to arotinib or its preventive drugs;

- Subjects who are participating in other clinical studies or whose first medication
is less than 4 weeks from the end of the previous clinical study (the last
medication), or who have 5 half-lives of the study drug;

- Subjects are known to have a history of abuse of psychotropic substances, alcohol
abuse or drug abuse;

- The researcher believes that there are any conditions that may damage the subject or
cause the subject to fail to meet or perform the research requirements

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 70 Years
Countries
China
Locations

The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China

Contacts

Liu Hong
+86-13709284513
hongliu1@fmmu.edu.cn

Wei Zhou
0086-13709284513
252376698@qq.com

Liu Hong, Study Chair
Air Force Military Medical University, China

Xijing Hospital
NCT Number
MeSH Terms
Stomach Neoplasms
Oxaliplatin