SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYunpeng Liu

About this trial

To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;

Age 18-75 years, including 18 and 75 year, male and female;

ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;

Has a life expectancy of greater than 3 months;

Disqualifiers

Patients with meningeal metastases; Or patients with brain metastases that have not been treated with surgery or radiation, but those who have been stable for at least one month after treatment and have stopped using steroid drugs (such as 10mg/day prednisone or other equivalent hormones) for more than 2 weeks except;

Uncontrolled pleural effusion or ascites;

There are serious concomitant diseases: such as serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, hematopoietic disease, endocrine disease, cachexia, etc;

Previously received antibody drug conjugate therapy containing topoisomerase I inhibitors, such as trastuzumab deruxtecan (DS-8201), etc; Subjects underwent surgery (except diagnostic surgery), radiotherapy, chemotherapy, macromolecular targeted therapy or immunotherapy within 4 weeks before the first dose of the study drug;Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) whose last dose is less than 5 half-life period or 4 weeks (whichever is shorter) from the first dose; Subjects received palliative radiotherapy or local treatment less than 2 weeks after completion of treatment and before the first dose;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1811 & Apartinib

    Drug

    SHR-A1811 injection will be administered by intravenous infusion. And apatinib will be administered orally.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Gastric or gastroesophageal junction adenocarcinomaExperimental treatment 1 intervention
Group B: Advanced colorectal cancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 month

Secondary outcomes

1

Duration of Response (DOR)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 12 months
2

Disease control rate (DCR)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 month
3

Progression-free survival (PFS)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 month
4

Overall survival (OS)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yunpeng Liu

Lead sponsor

China Medical University, China

Sponsor institution

Jiangsu HengRui Medicine Co., Ltd.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: