The Combination of Immunotherapy and Stereotactic Ablative Radiotherapy in Oligometastatic Gastrointestinal Cancer

Sponsor
Fudan University
Study ID
NCT04625894
Phase
PHASE1
Status
Unknown

Conditions

  • Oligometastatic Gastrointestinal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Ablative Radiotherapy (SABR) — RADIATION
    To irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate. Target dose will be adjusted depending on site of the lesion and organs at risk (BED \> 100Gy). Sequence of irradiation for multiple metastases will be at the discretion of the investigators based on their experience.
  • Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cycle — DRUG
    Administration of Carrelizumab will be started within one week upon SABR completion, and will be continued for up to two years until disease progression, unacceptable toxicity or patient withdrawal.

Study Details

This is a single-center, open-label, single-arm phase I clinical study to exploratory observe and evaluate the efficacy and safety of anti-PD-1 antibody (Camrelizumab for Injection) combined with multisite stereotactic ablative radiotherapy (SABR) in patients with oligometastatic gastrointestinal cancer. According to the origin site of metastases, this study will consist of three subgroups, including gastric carcinoma group, colorectal carcinoma group and hepatocellular carcinoma group. For each of the subgroup, seven eligible patients with oligometastatic cancer originating from stomach, colon and liver, respectively will be recruited. All patients will receive multisite SABR followed by immunotherapy of Camrelizumab within one week from completion. Camrelizumab will be administered at a fixed dose of 200 mg intravenously (iv) on D1 in a 14-day cycle. The treatment will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal. Tumor tissue samples, sections, paraffin blocks or biopsy blocks, and biomarkers, including but not limited to PD-L1 expression level and the proportion of positive cells, TMB level and MMR status, will be collected from subjects.

Key Dates

Start date
Dec 31, 2020
Status verified
Nov 2020
Primary completion
Dec 31, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Patients with oligometastatic gastrointestinal cancer will receive multisite SABR, followed by Camrelizumab within one week from completion of radiation. Camrelizumab for injection at 200 mg, d1, q2w, 14-day cycle will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal.

Primary Outcome Measure

Dose-limiting toxicities (DLT) [ Time Frame: Up to 2 years ]

Central Contacts