A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors

Age 18~75 years old

Source text not verified

Eastern Cooperative Oncology Group (ECOG) score: 0~1 point

Expected survival is more than 3 months

Subjects diagnosed by histopathological or cytology with hepatocellular carcinoma or gastric adenocarcinoma/adenocarcinoma of the gastroesophageal junction or non-small cell lung cancer or urothelial carcinoma or esophageal squamous cell carcinoma

Previous treatment failure with at least one anti-angiogenic drug (such as sorafenib, lenvatinib, donafenib, bevacizumab, etc.)

Previous treatment failure with one immune checkpoint inhibitor (such as PD-1)

Source text: Previous treatment failure with one immune checkpoint inhibitor (such as PD-1, etc.)

Barcelona clinical liver cancer stage (BCLC stage) of stage C, or stage B subjects not suitable for local therapy or refractory to local therapy and not suitable for radical treatment

Source text: Subjects with Barcelona clinical liver cancer stage (BCLC stage) of stage C, or stage B subjects who are not suitable for local therapy or refractory to local therapy and are not suitable for radical treatment

Failed first-line standard chemotherapy (not less than 2 cycles) for advanced gastric adenocarcinoma/gastroesophageal junction adenocarcinoma

Source text: advanced gastric adenocarcinoma/gastroesophageal junction adenocarcinoma who have failed first-line standard chemotherapy (treatment of not less than 2 cycles)

Disease progression during first-line treatment or within 4 months after last dose

Source text: disease progression occurs during first-line treatment, or disease progression occurs within 4 months after the last dose (including mono-therapy maintenance for first-line therapy) after the end of treatment

Recurrence or metastasis during neoadjuvant or adjuvant therapy or within 6 months after last dose

Source text: recurrence or metastasis during neoadjuvant or adjuvant therapy or within 6 months after the last dose is considered to be a failure of first-line systemic chemotherapy for advanced disease

Central nervous system (CNS) metastasis with no clinical symptoms or clinically controlled symptoms with stability >= 4 weeks

Source text: Central nervous system (CNS) metastasis with no clinical symptoms or is accompanied by clinical symptoms, but the condition is controlled after treatment and the stability time is >= 4 weeks

Advanced non-small cell lung cancer subjects at stage III.B, III.C or IV

Source text: non-small cell lung cancer subjects who meet stage III.B/III.C/IV

Previous failure of PD-1 inhibitors monotherapy or in combination with platinum-based chemotherapy in advanced NSCLC

Source text: previous failure of PD-1 inhibitors monotherapy or in combination with platinum-based chemotherapy

Prior treatment for urothelial carcinoma including cisplatin chemotherapy with radiographic progression or recurrence, carboplatin chemotherapy with radiographic progression or recurrence, or not suitable for platinum chemotherapy

Source text: The previous treatment of patients with urothelial carcinoma meets any of the following: 1. Those who can tolerate cisplatin chemotherapy have radiographically confirmed disease progression or recurrence during or after treatment; 2. Those who cannot tolerate cisplatin chemotherapy, but can use carboplatin, etc., and radiographically confirmed disease progression or recurrence occurs during or after treatment; 3. Not suitable for platinum-containing chemotherapy

Previous failure with immune checkpoint inhibition agents such as PD-1/PD-L1 for advanced esophageal squamous cell carcinoma

Source text: Patients with advanced esophageal squamous cell carcinoma failure with previous immune checkpoint suppression agents such as PD-1/PD-L1

Subjects with central nervous system metastases need to be excluded from cohorts 4 and 6

Source text: subjects with central nervous system metastases need to be excluded from cohorts 4 and 6

Previously diagnosed with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma by histology or cytology

Source text: Previously diagnosed with fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. by histology or cytology

Pathological histology classification is squamous cell carcinoma (adenosquamous carcinoma including squamous cell carcinoma), carcinoid tumor, undifferentiated carcinoma or other gastric cancer/gastroesophageal junction adenocarcinoma that cannot be classified

Exclusion of gastric adenocarcinoma/gastroesophageal junction adenocarcinoma known to be HER2-positive (unknown HER2 status must be confirmed locally); patients with disease progression after trastuzumab can be enrolled

Source text: Subjects with gastric adenocarcinoma/gastroesophageal junction adenocarcinoma known to be human epidermal growth factor receptor 2 (HER2)-positive (patients with unknown HER2 status must be confirmed at the local hospital) shall be excluded, but HER2-positive patients with disease progression after trastuzumab treatment can be enrolled

Previous treatment with anti-angiogenic drugs for non-hepatocellular carcinoma (cabozantinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab) excluded

Source text: Previous treatment with anti-angiogenic drugs such as cabozantinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab (except subjects with advanced hepatocellular carcinoma)

History of hepatic encephalopathy

Source text: History of hepatic brain

Main trunk of portal vein cancer thrombus invasion, inferior vena cava or heart involvement

Source text: According to imaging examination, the main trunk of the portal vein has cancer thrombus invasion, inferior vena cava or heart involvement

Hepatitis B combined with hepatitis C or hepatitis D infection excluded

Source text: Hepatitis B combined with hepatitis C or hepatitis D infection

History of or preparation for organ transplantation

Source text: Patients who are preparing for or have received organ transplantation in the past

Other malignant tumors within 5 years (except cured basal cell carcinoma of skin, prostate carcinoma in situ, and carcinoma in situ cervix)

Source text: Other malignant tumors within 5 years (except for cured basal cell carcinoma of the skin, prostate carcinoma in situ and carcinoma in situ of the cervix, etc.)

Conditions affecting oral drug intake such as inability to swallow, chronic diarrhea and intestinal obstruction

Source text: Those with a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.)

Moderate to severe ascites with clinical symptoms requiring repeated drainage

Source text: Patients with moderate to severe ascites with clinical symptoms requiring repeated drainage

Uncontrolled pleural effusion and pericardial effusion

Source text: Patients with uncontrolled pleural effusion and pericardial effusion

Any bleeding or bleeding events >= CTCAE grade 3 within 4 weeks before first dose

Source text: Patients with any bleeding or bleeding events >= CTCAE grade 3 within 4 weeks before the first dose

Arteriovenous thrombotic events within 6 months prior to first dose; allowed treatment with low molecular weight heparin; antiplatelet agents contraindicated

Source text: Patients with arteriovenous thrombotic events, such as cerebrovascular accident (including transient ischaemic attack), deep vein thrombosis, and pulmonary embolism, within 6 months prior to the first dose, are allowed to be treated with low molecular weight heparin, and antiplatelet agents are contraindicated throughout the study period

No radiotherapy, chemotherapy, surgery, etc. within less than 4 weeks before first dose

Source text: Those who have previously received radiotherapy, chemotherapy, surgery, etc., within less than 4 weeks before the first dose of study drug

No less than 5 half-lives of oral targeted drugs

Source text: less than 5 half-lives of oral targeted drugs

No less than 14 days of oral fluorouracils

Source text: less than 14 days of oral fluorouracils

Unhealed wounds, fractures, active ulcers of stomach and duodenum, persistent positive fecal occult blood, ulcerative colitis, or other GI conditions causing bleeding or perforation

Source text: There are unhealed wounds, fractures, active ulcers of the stomach and duodenum, persistent positive fecal occult blood, ulcerative colitis, etc., or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigators

Liver cancer subjects have history of gastrointestinal bleeding within 6 months before first dose

Source text: Liver cancer subjects have a history of gastrointestinal bleeding within 6 months before the first dose

Patients with portal hypertension having high bleeding risk or red sign confirmed by gastroscopy

Source text: Patients with portal hypertension have a high risk of bleeding considered by the investigators, or have a red sign confirmed by gastroscopy or gastroscopy

Other factors determined by investigator making subject unsuitable for study participation

Source text: Other factors that the investigator determines that the subjects are not suitable to participate in this study

Subjects with EGFR mutation and known ALK translocation excluded (advanced non-small cell lung cancer)

Source text: Subjects with Epidermal Growth Factor Receptor (EGFR) mutation and known anaplastic lymphoma kinase (ALK) translocation (for Advanced non-small cell lung cancer)

Central squamous cell carcinoma with large hemoptysis risk excluded (advanced NSCLC)

Source text: Central squamous cell carcinoma with large hemoptysis risk (for Advanced non-small cell lung cancer)