Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal Cancer

NCT04777162 | Unknown Phase 2

• 1 other identifier: Tislelizumab plus Anlotinib
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Immunotherapy acquired resistance was observed in clinical practice. The investigators intended to add anlotinib to PD-1 inhibitors, hoping reverse the resistance.

Conditions

Gastric Cancer; Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  the rate of patients reached PR or CR based on RECIST 1.1

  2 years

Secondary Outcomes (2)

• progression-free survival

  Up to 2 years

• overall survival

  Up to 2 years

Study Arms (1)

tislelizumab+anlotinib

EXPERIMENTAL

patients will be administrate with dual drugs, tislelizumab plus anlotinib.

Drug: Tislelizumab; Drug: Anlotinib

Interventions

Tislelizumab DRUG

For included participants, tislelizumab would be administrated 200mg q3w iv.

tislelizumab+anlotinib

Anlotinib DRUG

Patients will be administrated with Anlotinib 12mg p.o. d1-d14 q3w.

tislelizumab+anlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG scored 0 or 1, ≥18 years old, expected OS≥3 months;
• Histology confirmed unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma or colorectal cancer;
• ≥1 evaluable lesion based on RECIST 1.1;
• Patients received PD-1/PD-L1 in the last treatment line, and should meet following conditions:
• i) there was no severe immune-related adverse events, ii) the duration between tumor progression and screening should be 3-12 weeks, iii) the best evaluation results should be PR or CR when receiving PD-1/PD-L1 treatment but progression was confirmed in the latest evaluation, iv) patients were diagnosed with special pathology subtypes, that are sensitive to immunotherapy, such as dMMR, MSI-H tumors, or gastric cancer with PD-L1 CPS≥10, PFS≥6 months in the last treatment line;
• laboratory test should meet following standard: i) HB≥90g/l, neutrophils≥1.5\*10\^9/L, plt≥100\*10\^9, ii) ALT and AST\<2.5xULN (5ULN for liver metastatic patients), TBIL≤2×ULN, Cr≤1.5×ULN, and Ccr\>50μmol/L iii) APTT, INR and PT≤1.5×ULN iv) LVEF≥50%
• for female participants, Hcg should be negative and both male and female participants should have contraception measures
• participants should be informed consent, and voluntary.

You may not qualify if:

• received anlotinib or other TKIs previously;
• allergic to other monoclonal antibody before the treatment;
• diagnosed with other malignancy in last five years (cured skin basal carcinoma, prostate cancer or cervical caner in situ were excluded)
• concurrent with other active autoimmune disease;
• any condition that require immune suppressor, such as cortisol (\>10mg/d prednisone equally), CTX;
• conditions affect oral absorption (eg: dysphagia, intestinal obstruction; chronic diarrhea);
• uncontrolled pleural effusion, hydropericardium and seroperitoneum;
• brain metastasis;
• received other anti-tumor treatment in past 3 weeks, eg: surgery, radiotherapy, target therapy, immunotherapy, and traditional Chinese therapy (target therapy less than 5 half-life period, 5-Fu less than 14 days were excluded);
• concurrent with uncontrolled other diseases, i) hypertension (\>150/90mmHg) ii) unstable angina pectoris, ≥ level 2 heart failure, arrhythmia within last 6 months; iii) clinical meaningful liver disease, eg: active HBV/HCV hepatitis; iv) HIV positive; v) uncontrolled diabetes; vi) urine protein ≥++ or 24h urine protein \>1g;
• injected vaccine in past 4 weeks, or administrated with antibiotics;
• investigator assumed improper conditions, such as mental disease, family or society factors.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Colonic Neoplasms

Interventions

tislelizumab; anlotinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)