Recruiting

Carilizumab and Apatinib for Unresectable Stage III and IV dMMR Gastric Cancer

What is being tested

Carilizumab and Apatinib

Drug

Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

Over 18 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: April 2023

See protocol details

Summary

Principal SponsorPeking University Third Hospital

Study ContactYanhong Yao

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 20, 2023

Actual date on which the first participant was enrolled.

This clinical study is exploring a new treatment combination for patients with advanced stages of a specific type of stomach cancer known as dMMR gastric cancer. These patients are unable to have surgery to remove the cancer because it is too advanced. The study tests if using two drugs, Carilizumab, a PD-1 antibody, and Apatinib, can make surgery possible by shrinking the cancer. The goal is to see if this combination can keep the cancer from progressing for at least a year, which could offer new hope for patients who currently have limited treatment options. Participants in the study will receive Carilizumab and Apatinib every 21 days. After every two treatment cycles, doctors will check if the cancer has shrunk enough for surgery. If surgery becomes possible, Apatinib is paused for a short time, and an extra dose of Carilizumab is given to prepare. Surgery is scheduled 3 to 6 weeks after the last dose. After surgery, or if surgery isn't possible, participants will continue receiving the combination treatment until the cancer worsens, they experience a recurrence, or for up to two years. Regular follow-ups will track their health and any further treatments. This process allows researchers to closely monitor the safety and effectiveness of the treatment.

Official TitleSingle Center, Phase II Clinical Study of PD-1 Antibody Carilizumab Combined with Apatinib for Unresectable Stage III and IV DMMR Gastric Cancer

NCT06792162

Principal SponsorPeking University Third Hospital

Study ContactYanhong Yao

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

11 inclusion criteria required to participate

Age greater than or equal to 18 years old, gender not limited;

Histologically confirmed unresectable stage III and IV dMMR (complete loss of at least one protein, MLH1, PMS2, MSH2, and MSH6), gastric adenocarcinoma (GC) (excluding neuroendocrine tumors) or gastroesophageal junction adenocarcinoma (GEJ);

Unresectable gastric cancer patients with potential for conversion therapy, defined as gastric cancer patients with single organ metastasis (such as liver metastasis, ovarian metastasis, lung metastasis), retroperitoneal lymph node metastasis, supraclavicular lymph node metastasis, localized peritoneal metastasis, invasion of surrounding organs, and other gastric cancer patients evaluated by researchers as feasible for conversion therapy;

Without surgery, radiation therapy, or immunotherapy for the gastric cancer lesion or metastatic tumor.

Show More Criteria

13 exclusion criteria prevent from participating

Other malignant tumors have been diagnosed within 5 years before the first use of the investigational drug, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma and/or effectively resected cervical carcinoma in situ and/or breast cancer and/or thyroid cancer and other malignant tumors that have achieved long-term survival;

Suffering from any active autoimmune disease or history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (except for patients with stable hormone levels after treatment); Subjects with childhood asthma who have been completely relieved and do not require any intervention or vitiligo in adulthood may be included, but those who require medical intervention with bronchodilators may not be included;

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 is positive, and HCV-RNA is higher than the detection limit of the analytical method) or people with co infection of hepatitis B and hepatitis C;

Within 14 days prior to the first use of the investigational drug, immunosuppressive drugs have been used, excluding nasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e. not exceeding 10 mg/day of prednisolone or other corticosteroids at physiological doses of equivalent drugs);

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive Carilizumab 200mg repeated every 21 days and Apatinib 250mg everyday

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Peking University third hospital

Beijing, ChinaOpen Peking University third hospital in Google Maps

Recruiting

One Study Center