FMT+ QL1706+bevacizumab+ XELOX As First-line Treatment for Advanced MSS-type Colon Cancer with Liver Metastasis

Program Status

Not yet recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Tags

MSS/ MMRp

Comments

Trial only in China. For MSS CRC metastatic patients with liver metastases, who are about to receive first line standard of care treatment. Fecal transplant plus chemo plus immunotherapy.

Fecal microbiota transplantation (FMT): administered 2 days before systemic treatment, with the aim to reconstruct intestinal microecology. Experimental.

Systemic treatment:
QL1706: immunotherapy, PDL1/CTLA4 bispecific (similar to a combination of pembrolizumab and ipilimumab). Experimental.
Bevacizumab (Avastin): monoclonal antibody, anti VEGF, standard of care.
XELOX: chemotherapy, combination of  capecitabine (Xeloda, oral) and oxaliplatin (intravenous), standard of care.

Inclusion criteria seems to include only KRAS / RAS mutant CRC cancers, since it indicates “excluded Ras, Raf wild type”, but it is suggested to contact the research team for confirmation.

Contacts

Hua Jiang MD
CONTACT
+86-18015852711 czeyjh@njmu.edu.cn

Inclusion Criteria

Inclusion Criteria:

1. Histological or cytological confirmed advanced colon cancer with liver metastasis.
2. Signed written informed consent.
3. Have not received anti-tumor treatment.
4. According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1.
5. Patients of both sexes, aged ≥18 years and ≤75 years.
6. ECOG PS 0-1;
7. Expected survival time ≥ 3 months;
8. Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements, as follows:

1) Blood routine: ANC ≥ 1.5 × 10^9/L, Platelet count ≥ 100 × 10^9/L, HGB ≥100 g/L (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: TBIL ≤1.5 x ULN; ALT/AST ≤ 5 x ULN; ALP ≤5×ULN; 3) Renal function: Cr ≤1.5×ULN, or creatinine clearance ≥50 mL/min: Urine routine results showed urinary protein < 2+; 4) Coagulation function: INR or PT ≤1.5 x ULN. 9.For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration.

10. For women of childbearing potential (WOCBP): agreement to refrain from heterosexual intercourse or use contraception.

11. For men: agreement to refrain from heterosexual intercourse or use a condom, and agreement to refrain from donating sperm.

Exclusion Criteria

Exclusion Criteria:

1. Suffered from other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid carcinoma.
2. Patients requiring elective surgery during the trial.
3. Patients who cannot take oral drugs, or have conditions that the investigator determines to significantly affect gastrointestinal absorption, such as chronic diarrhea, intestinal obstruction, etc., and are not suitable for treatment.
4. Patients during pregnancy (positive pregnancy test) or lactation.
5. Central nervous system metastasis or meningeal metastasis.
6. Uncontrollable bone metastasis, or patients at risk of fracture, requiring surgery, local radiation therapy.
7. Patients with active infection requiring systemic anti-infection treatment.
8. Patients with a history of immunodeficiency, including those who are positive for HIV antibody tests.
9. Patients with known, active autoimmune diseases.
10. Patients with uncontrolled active hepatitis B, patients with hepatitis C virus infection (HCV antibody positive).
11. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe arrhythmia, acute coronary syndrome within 6 months, congestive heart failure, aortic dissection, stroke, and T IA history.
12. Severe bleeding events occur within half a year, or high bleeding risk factors such as active digestive tract ulcers and esophageal and gastric varices due to liver cirrhosis.
13. Patients with diabetes who cannot be stably controlled by drugs (including insulin).
14. Mental or language disorders that prevent communication with the patient;
15. Patients participating in another clinical trial.
16. MSI-H/ d MMR without immunotherapy; left colorectum of Ras, Raf wild-type.
17. The investigator believes that the subject has other serious systemic diseases or other conditions that make him unsuitable for participation in this trial.

NCT ID

NCT06801665

Date Trial Added

2025-01-30

Updated Date

2025-03-25